QA Engineer

  • Contract type Temporary Assignment - until further notice
  • Place
    Yverdon Les Bains
  • Reference 207346-13-4
  • Assignment start date Asap
  • Sector Chemistry & Life Sciences
  • Publication date 08.06.2021
  • Apply

For the commissioning stage of a new green-field large scale API bio-manufacturing facility of our client, based in Yverdon-les-Bains we are welcoming bright professionals to apply to the position of a

QA Engineer

Your assignment

- Act as the main QA point of contact for all quality compliance key topics regarding DSP Equipment
- QA lead for implementation of Manufacturing execution System (MES) implementation in DSP
- Define Master Batch records Management process
- Review and approve MBRs, specifications and Material Master data
- Support definition of batch record review process (review by exception)
- Review executed batch records
- Manage deviations, CAPA and Change controls
- Lead implementation of data integrity requirements in the DSP area
- Roll-out the process to authorize the start of GMP operations in each Site areas
- QA lead in defined risk assessment activities
- Support the implementation of the bioplant manufacturing operations (GMP site readiness) as well as the associated documentation.
- Support the creation of operational procedures,
- Contribute to suppliers auditing
- Support the Commissioning & Qualification activities
- Act within compliance and legal requirements as well as within company guidelines
- Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
- At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)
- Contribute positively to a strong culture of business integrity and ethics

Your profile

- Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing. An advances degree is a plus.
- Speak, read and write in English and French
- Minimum of 5 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
- Thorough knowledge of biotechnology processes and manufacturing
- Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations and standards related to qualification and validation, including data integrity and laboratory GAMP.
- Proficiency with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
- Ability to make pragmatic and compliant decisions
- Strong result orientation and committed team member
- Flexibility
- Excellent written and verbal communication skills.

Interested?

Possibilities of a career growth and daily challenges awaiting those who apply and succeed.

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

I'd like to apply

Your Manpower consultant
Inessa Duerst

Life Sciences Competence Center
Picassoplatz 4
4052 Basle

T: +41 58 307 2441



Speculative application

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