Project Quality Manager (f/m/o) 100%

29.05.Position with re­spon­si­bil­i­ties100%

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in Basel we are looking for

Project Quality Manager (f/m/o) 100%

Main Duty:
The Quality Manager (QAM) is part of the process-transfer project team and provides all quality and compliance related guidance and support. Approve and maintain quality oversight with respect to supply of materials to our client, from global external suppliers and CMOs of chemicals and Drug Substances and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMP’s, regulatory requirements, our client's Quality Manual and Pharma industry practices.
 
Your tasks:
  • 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.
  • Support Supplier Audits and Following up on Audit CAPA activities
  • Review of ICH M7 questionnaires
  • Management of Deviations /OOS results (TrackWise/AQWA)
  • Assuring cGMP compliance of DS manufacturing, testing and release
  • Regulatory Compliance checks
  • Review of manually generated CoAs to support submission activities
  • Review of approval of SAP changes to inspection plans
  • Review and approval of registration modules as required for submissions (Subway)
  • Drafting and approval of different statements (for registration and material qualification purposes)
  • Generation of responses to Health Authorit queries
  • Site visits if required
  • Preparation of APR / PQR
  • Creates/Review/approval of supplier annual monitoring reports
  • Maintenance of compliance systesms e.g. supplier matter list, GMP certificate database
  • Transfer of suppliers' QA oversight to ESA QA Managers after project is completed
Your profile:
  • Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related sciences
  • fluent in English (spoken & written)
  • minimum 3 years experiences in pharmaceutical industry
  • minimum 3 years experiences in operational quality assurance. Good knowledge of cGmP requirements for major regulated markets (EU, US)
  • experienced in project management
  • experienced with IT-tools like Trackwise (AQWA), Subway, Agile desirable
Duration: 12 month
start date: asap
Workload: 100%
Location: Basel

Interested ?
We are looking forward to get your application via our homepage or directly to nancy.sommer@peppercorn.ch
 

Peppercorn Human Experts AG
Sommer Nancy
Claragraben 132A
CH-4057 Basel