Set up as a new job alert
Set up as a new job alert
Enter your email below to receive alerts to your inbox when similar jobs become available.
By clicking "Yes, send me jobs" below you are consenting to receive jobs to your inbox, based on the search criteria you have selected, as per our privacy policy.
By clicking "Yes, send me jobs" below you are consenting to receive jobs to your inbox, based on the search criteria you have selected, as per our privacy policy.
Thank you for signing up for a Job Alert
12223en
- Contract
- English
- Mid-Senior level
- Research & Development
- Basel
- Healthcare & Life Sciences
Skills
Quality, QA, QC, cGMP, Regulatory Compliance
Click here to get a notification every time a job like this gets added
Great news! We will let you know when a new job like this has been added!
This vacancy has now expired
For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Quality Manager, Teamleader QA.
Job Title: Project Quality Manager
Duration: 12 months
Your mission:
- Management of Change Controls (Agile)
- Review and approval of transfer protocols
- Support of supplier qualification/certification
- Preparation and alignment of Quality Assurance Agreement (QAA)
- Review and approval of Master Batch Records, validation protocols & reports, Quality Risk Assessments, Testing Monographs etc.
- Supporting Supplier Audits and Following up on Audit CAPA activities
- Management of Deviations / OOS results (TrackWise/AQWA)
- Assuring cGMP compliance of DS manufacturing, testing and release
- Regulatory Compliance checks
- Review and approval of registration modules as required for submissions (Subway)
- Generation of responses to Health Authority queries
- Site visits if required
- Preparation of APR / PQR
The ideal candidate:
- Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
- Minimum 3 years of experience in in the pharmaceutical industry
- Minimum 3 years of experience in operational quality assurance
- Good knowledge of cGMP requirements for major regulated markets (EU, US)
- Project work experience required
- Experience with IT tools like Trackwise (AQWA), Subway, Agile desirable
- Fluent in English -spoken and written
Job Title: Project Quality Manager
Duration: 12 months
Your mission:
- Management of Change Controls (Agile)
- Review and approval of transfer protocols
- Support of supplier qualification/certification
- Preparation and alignment of Quality Assurance Agreement (QAA)
- Review and approval of Master Batch Records, validation protocols & reports, Quality Risk Assessments, Testing Monographs etc.
- Supporting Supplier Audits and Following up on Audit CAPA activities
- Management of Deviations / OOS results (TrackWise/AQWA)
- Assuring cGMP compliance of DS manufacturing, testing and release
- Regulatory Compliance checks
- Review and approval of registration modules as required for submissions (Subway)
- Generation of responses to Health Authority queries
- Site visits if required
- Preparation of APR / PQR
The ideal candidate:
- Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
- Minimum 3 years of experience in in the pharmaceutical industry
- Minimum 3 years of experience in operational quality assurance
- Good knowledge of cGMP requirements for major regulated markets (EU, US)
- Project work experience required
- Experience with IT tools like Trackwise (AQWA), Subway, Agile desirable
- Fluent in English -spoken and written
