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Empower3 Support Specialist 50%

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.

One of our clients is looking for anEmpower3 Support Specialist for a 12-month contract in Kaiseraugst, Switzerland with a 50% work load.

Your tasks & responsibilities

  • 3rd level support for EMPOWER3 system
  • Roll-out coordination
  • Site implementation support

What you must have

  • 2 to 5 years of experience for working in regulated environments
  • Basic knowledge about chromatography as analysis technique
  • Analytical laboratory background
  • Exprience in lab environments
  • Experience with Waters Empower software will be a plus
  • German/English language (writing and speaking, both mandatory)
  • Good Communication skills

General information

  • Start date: 01. July 2019
  • End date: 30. June 2020 (one-year duration)
  • Extension: An extension is currently not planned
  • Work load: 50%
  • Working days: No preference
  • Work location: Kaiseraugst
  • Remote: Not possible
  • Travel: Up to 20% possible to Basel for hands on support

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell  via email

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For our client in Basel we are looking for a Medical Device Project Leader for a 12-month contract.

Duration: 01/07/2019 to 30/06/2020

Location: Basel

Workload: 100%

Job Purpose

The successful candidate for this position will need to be able to lead the technical development of packaging and/or drug delivery systems within the Novartis Packaging & Device Development Team, from early phase activities up to commercialization and production scale up. In addition to outstanding project management and inter-personal skills, a strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners.

Accountabilities:

    • Leading the definition of product requirements for packaging, medical devices, delivery systems, eg drug/device combination products in which the device is generally already registered but sometimes to be developed
    • Leading the collaboration with external development partners:
      - Monitor work progress according to plan
      - Monitor, support and challenge technical development as well as test and verification work
      - Monitor development and implementation of manufacturing processes
    • Managing the collaboration with internal development partners and stakeholders
    • Evaluating and challenging technical solutions
    • Supporting and coordinating the manufacturing of clinical material and the production scale up
    • Supporting cross functional project teams in the development, review and submission of regulatory dossiers
    • Managing and monitoring Human Factors Engineering activities
    • Major accountabilities:
    • Thorough project planning
    • Provide primary packaging and device expertise in a broader cross-functional drug product development team
    • Leading Risk management activities
    • Planning and monitoring of design verification activities (in-house)
    • Leading and authoring technical documentation
    • Ensuring a high quality Design History file
    • Transfer of Design History File to production

Education:

    • Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education

Language:

    • Fluent English (oral and written)
    • Proficiency in German/French advantageous

Experience/Professional requirement:

An ideal candidate would have a relevant degree in engineering and at least 7 years' experience in leading device development technical teams in a similar area

    • Good understanding of pharmaceutical development in general
    • Experience in project/program management of complex projects
    • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
    • Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
    • Considerable experience of managing external suppliers
    • Mechanical engineering in general

Product design/Design for manufacture

Test and verification, incl. development of methods and equipment

    • General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
    • Good communication and conflict solving skills

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you.

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My client is a massive company located near Antwerp, Belgium and they are currently searching for an experienced Embedded C Programmer to join their busy team on a contract basis.

The company itself develop tiny devices that they manufacture themselves all in house, including the Software. They are in a period of new development and are looking for an experienced Embedded C Programmer to help them at the point of the development cycle of which they are currently at. The one main thing about this role is that they need a good developer with a focus on C as they have a good amount of C developers currently.

This is a 6 months contract with the view to extend for a further 18 months due to the length and development cycle of the project. The pay rate for this role is around €65 - €75 per hour.

Requirements of the Embedded C Programmer:

- 5 years of experience in the field of Embedded Devices and programming with C (desirable) and C (essential).

- Eligibility to work in the EU

- Experience working with Electronics

- Antenna and RF experience (desirable)

- Algorithm experience (desirable)

If you or someone you know might be interested in this Embedded C Programmer position, please get in touch immediately or click Apply now!

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For our Pharma client in Basel we are looking for a

Pharma Manufacturing Manager

Start: ASAP
Duration: 12 months
Location: Basel

Main tasks:

The EM Technical Contractor will be responsible for the technical interface between the company and Contract Manufacturers of consumer healthcare products, which include pharmaceutical products, dietary supplements, cosmetic products and/or medical devices.

The specific requirements are:

  • Support validation of manufacturing and packaging processes at Contract Manufacturers, for new products and for changes to existing products. Review and approve validation protocols and reports.
  • Review changes to manufacturing processes, raw material sources, manufacturing equipment, and evaluate technical requirements to implement change (eg determine if process validation is required).
  • Provide input/guidance into resolution of production issues/deviations to ensure continuity of Supply. Troubleshooting in manufacturing.
  • Other technical and change control work as needed

Qualification required:

  • BS or equivalent degree in Chemistry, Chemical Engineering, Pharmaceutical Technology, or equivalent
  • At least 7 years combined professional experience in the following functions in the (small molecule) pharmaceutical, regulated consumer healthcare, or consumer confectionary packaged goods industry, with a strong technical focus on:
  • Process Technology
  • Technical transfer from development to manufacturing site or from site to site
  • Process validation
  • Manufacturing
  • GMP knowledge is a plus
  • Fluent in English, written and spoken

Are you interested to work in this challenging position? Alessia Biassoli, Senior MSP Consultant, is looking forward to receiving your complete profile. Please send an e-mail (see below)

By sending us your CV per E-Mail you are giving us your consent to the processing of your personal data according to our Data Privacy Policy.

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For our client in Rotkreuz (Switzerland) we are looking for a Regulatory Affairs Assistant for a 6 month contract
Duration: 6 month, starting as soon as possible
Location: Rotkreuz
Workload: 80% - 100%

Job Purpose:
Takes care of scanning and archiving of regulatory dossiers to ensure a compliant electronic archiving.

Additional Information:
- You have the opportunity to learn the structure of regulatory documentation.
- You are coordinating the availability of hard copy of the regulatory documentation with our out-sourced archive.
- You keep an overall overview on status of the project by maintaining a consistent and precise tracking.
- You are working in independent manner, you are well organized and structured.
- You work in collaboration with RA Manager.

Major Accountabilities:
- Scanning of regulatory dossier
- Archiving according e-doc format in our system
- Track the status of the project for each dossier
- Coordinate the availability of hard copy of the regulatory documentation with our out-sourced archive.

Requirements:
- Pharmaceutical/technical/medical associate education or similar education, who looks for insight in regulatory
- Fluent in English and German
- Very good MS Office Skills, Organizational Skills, project management skills
- Structured and accurate working style, Like to drive a project with independent manner, Emphatic, powerful and courageous, A strong team player who gets to the front, shows flexibility in a changing environment and always fights for excellent results

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Empower3 Support Specialist - CSV - Quality - Regulated Enviroment - Analytical laboratory - MIT systems in lab environment - Waters Empower software - English - German - Pharmaceutical - 50% workload - Switzerland

NextLink is having an existing position as a German Speaking Empower3 Support Specialist with 50% workload for global projects in Switzerland for our core client within Pharmaceutical industry.

General information:

Start date: 01. July 2019
End date: 30. June 2020 (one year duration)
Extension: An extension is currently not planned.
Work load: 50%
Working days: No preference.
Work location: Kaiseraugst
Remote: Not possible.
Travel: Up to 20% possible to Basel for hands on support.

Task & Responsabilities:

3th level support for EMPOWER3 system
Roll-out coordination
Site implementation support

Must haves:

2 to 5 years of experience for working in regulated environments
Basic knowledge about chromatography as analysis technique
Analytical laboratory background
Advanced skills for IT systems in lab environments
Experience with Waters Empower software
CSV background and experience in working with Quality
German/English language (writing and speaking, both mandatory)
Communication skills

Nice to have:

Minimum 2 years of experience in using Waters EMPOWER software
French language

Pharmaceutical

If you are interested and available please call Diana or send me your most up to date CV on: (see below)

Apply

For our client in Kaiseraugst we are looking for Senior Data Architect (Scientific & Manufacturing) for 6-month contract.

Job title: Senior Data Architect (Scientific & Manufacturing)

Duration: 01/07/2019 to 31/12/2019

Location: Kaiseraugst

Workload: 100%

Our vision is to accelerate the generation of meaningful scientific insights through FAIR and SHARED data.

To do this, we are focusing on three key areas:
- Making Data FAIR and more easily consumed. FAIR data is well-organized to be Findable, Accessible, Interoperable, and Reusable for generating new scientific insights. EDIS is building an engine to make the FAIR way the easy way for managing data and developing resources to help embed FAIR practices into how we work.
- Instilling a new Data Citizenship Culture that recognizes shared data ownership and individual responsibility for its quality and availability for secondary use. EDIS aspires to shift our collective mindset from 'my data' to 'our data', where we all are accountable for ensuring it is trustworthy and managed with long-term reuse in mind.
- Making it easier to manage and share data to Maximize its Value for R&D insights and for our patients. EDIS is partnering with science to create a diverse set of data marts for enabling new analysis opportunities and delivering new tools, systems, and guidance that reduce barriers to internal data access and reuse.

The team:
As a member of the Scientific Decision Support Network in PD Informatics you will work closely with the Company programme team, specifically on the Dataset Catalogue and Data Integration Platform projects. In addition to EDIS the SDS network partners with the Company late stage Therapeutic Area teams, the R&D Planning and Excellence teams and the Biometrics Analytics group in developing the business understanding to effectively support opportunities enabled by Information and Technology.

Tasks & Responsibilities:
- Metadata management/RDF and modelling. Development of new and extension of existing ontologies.
- Partner with domain experts (technical and business) to define new models, identify metadata management needs and flows across systems in the area of data standards and clinical data management.
- Develop applications to optimize information flows with regards to clinical data standards and metadata management.
- Work closely with the development team to enhance/extend the functionalities of our semantic based metadata management platform.
- Investigate, expand, and advance our state of the art platform to support business needs and research related tools available on the market.
- Clinical domain knowledge
- Participate in cross-functional projects and initiatives that contribute to PHC programmes.

Must Haves:
- 5 years experience in Matadata modelling and standard definition in the clinical domain space
- Hands-on experience with Linked Data and Semantic Web technology stack: eg RDF, RDFS, OWL, SPARQL, SHACL
- Hands-on technical experience
- Knowledge on clinical data standards used in the pharma industry is of advantage
- Knowledge of the processes in pharma development is of advantage
- Excellent English communication (oral and written) and technical writing skills.
- strong communication skills: able to communicate complex topics in a simplified way to non-technical stakeholders
- strong influencing skills
- Ability to manage different stakeholders at different levels of seniority

Nice to Haves: 
CKAN knowledge is desirable
German is a plus

For further details please contact:
Anna Siemienkiewicz
(see below)

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Pharmatechnologist EFZ - GMP/German/3-shift

Job Description:
Our customer is looking for a Pharmatechnologist to handle automatic machines in GMP regulated environment.

Tasks and Responsibilities:
-Operation of fully automated systems, performing in-process controls
-Troubleshooting of equipment and maintenance
-Pay attention to GMP compliant work in its shift and reports abnormalities and deviations
-Work in hygienic conditions and ensure that the appropriate working conditions are maintained
-Close cooperation and intensive Communication with other departments
-Continuous optimization of workflow to increase quality and efficiency
-Ensures information flow between shifts and operators
-Ensures transparent and comprehensive shift transfer
-Informs, speaks to other areas along the manufacturing process to ensure smooth production
-Ensure compliance with occupational safety regulations 2/3
-Material management (stocktaking, scrapping, bookings)
-Customization of production plans
-Continuous optimization of workflow to improve quality and efficiency
-Create dispensing solutions and pastes for production
-Perform cleaning processes
-Produce, log and monitor every process step
-Shift (3 -shift Monday-Friday).

Must Haves:
-Handling of fully automatic machines in GMP regulated environment or ISO knowledge
-Production of thick film sensors
-High-precision work under clean room conditions
-At least 2 years professional experience
-Craftsmanship
-Ability to work under pressure

Education:
-Completed vocational training as chemical and pharmaceutical technologist EFZ, screen and stencil maker, offset printer or a technically related profession

Languages:
-German-Fluent
-English-Nice to have.

Reference No.: 918397NC
Role: Pharmatechnologist EFZ- GMP/German/3-shift
Industry: Pharma
Location: Lucerne und Region
Workload: 100%
Start Date: ASAP
Duration: 5 months

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

About us:
ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

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Major Activities:
Author 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.
Prepare CMC responses to health authority questions during development, registration and product life cycle.
Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
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.
Keep 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.
Establish and maintain sound working relationships with partners and customers.
Assume activities in support of the general department such as annual and product renewal writing coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Ideal Background

Education:
Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

Experience/Professional requirement:

Regulatory experience in drug/biopharmaceutical products
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.

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

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trustaff is seeking an experienced Pharmacist for a 13-week travel contract.

Enjoy the adventure of traveling while enjoying the benefits of working with trustaff.

Here are the top-tier benefits you will enjoy while traveling:

- Medical/Dental/Vision Insurance
- 401(k)
- Weekly Pay through Direct Deposit
- Earn Great Bonuses
- Licensure Reimbursement
- Clinical Liaisons
- 24/7 Personal Contact

Minimum Requirements:
- Minimum of one year of experience as a pharmacist in a clinical setting

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