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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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.
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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.
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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:
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.
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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:
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.
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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Your experience/skills:
Your tasks:
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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:
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.
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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:
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.