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Configuration Manager (m/w/d) - engineering/English/CMP/highly regulated/German

Project/Role:
For our client Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Configuration Manager (m/w/d)

Background:
The Department is looking for two Configuration Managers. The two position differ in terms of the Tasks & Responsibilities.

As part of the Diagnostics Governance & Services organization, the Configuration Management Team drives and to promotes an Integrated Configuration Management Process Excellence throughout Roche Diagnostics. We implement an End-to-End Configuration Management process in order to comply with applicable regulatory requirements, to enable managing the complexity and foster efficiency in the value chain by reducing rework and intervention resources, to know anytime the valid product design, build state and maintained configuration status of Roche DIA products and their components and to enable One Roche by common principles, standards and best practices in Configuration and Product Data Management throughout Roche Diagnostics.

Main Tasks

Prepare and update Configuration Management Plans (CMP) for products and projects
. Manage project and product Configuration Baselines and prepare and release:
- Configuration Baseline Plan
- Baseline Report
- Configuration Note
. Manage product Baseline documentation verification and release
. Build up and manage the project and product CI structure in close collaboration with Engineering
. Manage project and product CI change process
. Establish and manage a simplified and harmonized CM process across the division to execute the CM vision
- Identify, synchronize and monitor CM relevant initiatives
- Implement BPM Process Improvement Proposals (PIPs) in CM process
. Establish divisional CM framework that is applied over the product life cycle covering data, people, processes and tools
. Execute CM communication strategy to effectively engage with stakeholders
- Proactively communicate simplified CM processes and standards throughout Roche DIA 
- Actively engage with all involved disciplines in the value chain
. Continuously analyze and improve CM data, people, processes and tools

Tasks & Responsibilities
Configuration Management - Business Process Management (BPM):
* Establish CM Business Process Management (BPM) framework to consolidate and manage CM related activities across the division
. Build and strengthen BPM community
. Define and continuously improve BPM Process Improvement Proposal (PIP) process
. Organize and moderate BPM relevant meetings
. Establish and manage a simplified and harmonized CM process across the division to execute the CM vision
* Identify, synchronize and monitor CM relevant initiatives
. Implement BPM Process Improvement Proposals (PIPs) in CM process
. Establish divisional CM framework that is applied over the product life cycle covering data, people, processes and tools
. Develop and execute CM communication strategy to effectively engage with stakeholders
. Proactively communicate simplified CM processes and standards throughout Roche DIA
. Actively engage with all involved disciplines in the value chain
. Continuously analyze and improve CM data, people, processes and tools
. Prepare and update Configuration Management Plans (CMP) for products and projects
. Build up and manage the project and product CI structure in close collaboration with Engineering
. Manage project and product CI change process
. Manage project and product Configuration Baselines and prepare and release:
- Configuration Baseline Plan
- Configuration Note
. Manage product Baseline documentation verification and release

MUST Have:

Academic degree in field of engineering with minimum 3 years of experience in Technician or Engineering area
At least 3 years of experience in the domain of Product Lifecycle Management and Configuration Management
At least 3 years of experience in medical device or other highly regulated industries
At least 3 years of experience in industrial Product Lifecycle Management processes
Experience with PLM tools required preferably covering the domains of configuration, document and change management
Experience with translating project and process needs and deliverables in systematically structured product data and user requirements
Excellent communication skills and expertise in stakeholder management, ability to identify customer needs and develop creative solutions
Good knowledge of the English language is required. German is a plus

Reference No.: 920092SGR
Role: Configuration Manager
Industry: Pharma
Location: RotkreuR
Workload: 100%
Start: 01.04.2021
Duration: 12++
Deadline: 28.02.2021

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.

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We need an Architect good in communication with UX architecture, Agile and SharePoint experience.

This is a long term time & material role for our global client US site, but EU resource working in US time zone will work. Or local Us consultant.

Long term role.

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Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

  • Several years of experience in regulatory, as well as drug/biopharmaceuticals environment
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
  • Knowledge of the drug development process, regulations, guidelines for NCEs and product life cycle maintenance is of advantage
  • Outstanding risk assessment skills, paired with the ability to critically evaluate data from a broad range of scientific disciplines
  • Hands-on competency with collaborating successfully with extended, multinational project teams and coordinating several projects simultaneously
  • Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent qualification
  • Languages: English, fluent in written and spoken; any local language skills is a distinct advantage

Your tasks:

  • Authoring high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
  • Preparing CMC responses to health authority questions during development, registration and product life cycle
  • Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines
  • Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
  • Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

Start: ASAP
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH16648

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.

Going the Extra Mile.

As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions
  • Finding an apartment
  • Health- and social insurance
  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Apply

Senior Project Manager vacancy for a globally operating Basel based company in the pharma sector.

Your experience/skills:

  • Proven credentials for planning, executing, controlling as well as closing projects and the capability to manage numerous projects at the same time with minimal supervision
  • Experience of managing a PMO office as well as the complete life cycle of a project with multiple project teams
  • Proficiency in creating and maintaining project and programme plans including risks, actions, issues and dependencies
  • Profound understanding and knowledge of PM tools and methodologies paired with a high efficiency in resource planning and tasks assignment
  • Know-how of benefits and dependency mapping, risk management and resource planning as well as excellent interpersonal skills
  • Languages: English, fluent in written and spoken

Your tasks:

  • Implementing programme and project management plans along with monitoring risks, issues and milestones at the programme level
  • Collecting, consolidating and analysing data to track and report the programme status
  • Supporting the Programme Director ensuring all tasks are completed and deliverable are met
  • Ensuring dependencies are integrated into the programme schedule and are communicated as well as setting up and running programme governance
  • Assisting the Business Case and Benefits Management team regarding benefits tracking, programme costs and dashboard management
  • Being responsible to manage communications within the project team and out the Central PMO and different Support teams

Start: 03/2021
Duration: 08MM+
Location: Basel, Switzerland
Ref.Nr.: BH16651

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions
  • Finding an apartment
  • Health- and social insurance
  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Apply

Regional Operations Manager ICRO vacancy for a globally operating Basel based company in the pharma sector.

Your experience/skills:

  • 5+ years of working experience in a related role
  • Proficiency in operating model implementation, change management and organizational governance
  • Strong communication skills and the ability to work under pressure
  • Languages: English, fluent in written and spoken

Your tasks:

  • Providing project management and consultant support to Governance and Compliance
  • Preparing project deliverables related to implementation of new governance and operating model including analysis, design, planning and analysis
  • Organizing and facilitating meetings with important stakeholders
  • Assisting change management and implementation program as well as engaging with key stakeholders, communicating key messages and addressing problems and issues

Start: 03/2021
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH16652

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions
  • Finding an apartment
  • Health- and social insurance
  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Apply

New opportunity has been created for a junior Regulatory Affairs Specialist CMC in the global pharmaceutical company with HQ based in Basel.

Major Activities
1. Authoring CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle.
2. Prepare CMC responses to health authority questions during development, registration and product life cycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6. Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Requirements:
Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
Knowledge. experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
Effective planning, organizational and interpersonal skills.

This is a temporary contract role for 12 months with a great chance for extension.
Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

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Junior GPRM/RegCMC Manager vacancy for a globally operating Basel based company in the pharma sector.

Your experience/skills:

  • Professional experience in a regulatory environment, as well as in drug and biopharmaceuticals
  • Working knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
  • Know-how of drug development process, regulations, guidelines for NCEs and product life cycle maintenance is a plus
  • Ability to critically evaluate data from a broad range of scientific disciplines, work successfully with extended, multinational project teams and coordinate the projects accordingly
  • Graduate Degree in Science like Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or any other equivalent discipline
  • Languages: English, fluent in written and spoken, good local language skills are an asset

Your tasks:

  • Creating high-quality CMC documentation for HA submission with help and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
  • Meeting timelines and e-publishing requirements through the whole project life cycle as well as preparing CMC responses to health authority questions for the duration of the development, registration and product life cycle
  • Identifying necessary documentation for worldwide submissions and negotiate the delivery of approve technical source documents in alignment with project timelines
  • Detecting content, quality or timeliness problems and issues with source documents or any other possible authoring issues that influence the submission quality or timelines
  • Keeping wisdom and knowledge up to date regarding regulatory guidelines and requirements all over the world as well as for new technical trends
  • Being a member of the global team and actively participating and contributing to the regulatory strategy, identifying the critical problems and lessons learned

Start: ASAP
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH16649

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions
  • Finding an apartment
  • Health- and social insurance
  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Apply

For our Pharma client based in Basel, we are looking for a

Senior Quality Assurance Coordinator (manufacturing area) -100%

Duration: 1 year duration

Main TASKS and RESPONSIBILITIES:

  • Ensures and performs Quality Assurance (QA) operational activities, such as review of manufacturing batch records, release documentation of batches associated with Drug Product and Drug Substance
  • Manage deviations, CAPA and complaints, participate in escalation task force meetings
  • Provide batch record review and BoM (Bill of Materials) approval related to biologic and parenteral products ensuring reliable and safe drug supply to patients and compliance to regulatory and cGMP requirements
  • Prepare documents relevant to batch processing/shipping and market supply, eg CoA, CoC
  • Manage and track timely compilation and review of APR/PQR as well as trending analysis of data (eg QC, stability) provided by the CMO (Contract Manufacturing Organization)
  • Provides tracking and trending analysis/KPIs relevant to business processes
  • Perform CMO site visits for batch record review and Person-in-Plant activities
  • Coordinates change management activities, related documentation and propose requirements for technology transfers, process validation, cleaning validation, analytical methods validation, GDP, other CMC studies
  • Review and approve changes and reports (eg stability, qualification, validation)
  • Writes and reviews SOPs, provides QA input, review and approval of SOPs, TRDs (Technical Registration Documents) to assure regulatory compliance
  • Maintains awareness of current GMP trends and supports continuous improvement within the Quality Unit
  • Provides support for regulatory agency inspections and requests

EXPERIENCE REQUIRED:

  • Master's degree in (bio-)chemistry, pharmacy or biotechnology or similar education
  • Minimum of 5 years of professional experience in the field of quality assurance/quality control/validation in the pharmaceutical or related industries
  • Advanced knowledge and experience in (bio-)pharmaceutical subject matter areas including manufacturing of bulk, intermediates and final containers, discrepancy management, product inspection and labeling as well as contract manufacturing
  • Broad experience and knowledge in the field of cGMP, GDP, QA/QC and regulatory compliance (US and other international agencies)
  • Ability to propose and streamline business processes to maximize efficiencies, to resolve discrepancies and trending issues and able to adapt to changes in the organizational structure
  • Strong interpersonal skills as well as ability to accomplish objectives despite obstacles and setbacks
  • Excellent communication skills, good presentation and influencing skills
  • Proficiency in Microsoft Office (Word/Excel/Outlook) applications
  • Fluent in English is a must, knowledge of the German language is beneficial, any other languages are a plus
Apply

Utilities Operator (Pharma 100%)

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

On behalf of our client we are looking for a Utilities Operator, preferably with experience in the pharmaceutical industry.

Main tasks:

  • With Scada systems you monitor and control the builing utilities
  • You support the system operation and troubleshoot
  • You perform the maintenance and work revision
  • You fix errors on a technical level
  • You document, create reports, and keep track of all inspection through CMMS
  • You work with CAPAs and create event notification

Requirements:

  • You are a maintenance specialist or engineering operating mechanics with recognized certificate of competence
  • You have training in mecahnical/technical building
  • You already have at least 6 years of experience in operations of industrial systems
  • You have worked with DeltaV and SiemensDesigo
  • You have preferably experience in the phamaceutical industry

Do you bring all the requirements? Kindly send me your CV today through the link in the advert. Should you have any questions please contact Rosi Pang.


Apply

Regulatory Submission Publisher vacancy for a globally operating Basel based company in the pharma sector.

Your experience/skills:

  • 3+ years of working experience in Pharma or any other relatable industry
  • Familiarity with regulatory requirements
  • Strong knowledge on regulatory submission format with the focus on CTD and eCTD
  • Excellent understanding and skills with MS Office as well as publishing software like eCTDXpress, DocuBridge and more
  • Strengths include strong interpersonal communication skills and the ability to work effectively in cross-functional teams
  • Finished Bachelor Degree in life sciences or any other relevant discipline
  • Languages: English, fluent in written and spoken

Your tasks:

  • Producing, assembling and publishing electronic submissions per regulatory requirements with the attention on maintenance submissions worldwide including variations, response to list of questions and more
  • Organising internal publishing activities and liaises with cross functional teams as well as document authors to support with timelines and deliverables related to submission documents
  • Conducting quality control review tasks

Start: ASAP
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH16650

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

  • All administrative questions
  • Finding an apartment
  • Health- and social insurance
  • Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Apply