QA Manager - Inspection Management

Basel-Stadt  ‐ Vor Ort
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Schlagworte

Beschreibung

Randstad Professionals is actively seeking a Senior Quality Manager for their client in Basel. As a Quality Manager you support inspections as part of the compliance support group including the Drug Product Manufacturing.

Your responsibilities include

Primarily:

  • Main Responsibility for planning, coordination of self-inspections in Basel and Kaiseraugst
  • Performing self-inspections at Drug Product Manufacturing Basel
  • Responsibility for own implementation, documentation and tracking of self-inspections
  • Co-ordination, documentation and tracking of health authority and customer inspections
  • Ensuring the readiness inspection at the site regarding regulatory requirements

General Tasks:

  • Provide Production and Quality departments input to the review and approval of manufacturing and Quality related documents
  • Review of GMP documents as requested
  • Review current health authority observations and warning letters to monitor the inspection climate.
  • Participate in post-inspection activities including observation response process and commitment follow-up and tracking
  • Implement Inspection Readiness procedures and ensure inspection readiness for Kaiseraugst and Basel parenterals production
  • Conduct Inspection Readiness" training for managers, groups and SMEs
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Job Profile:

  • University degree in pharmacy, microbiology, chemistry or biochemistry or a similar training (eg, Quality Engineer)
  • Several years of professional experience in the pharmaceutical parenterals production and/or quality assurance and/or Quality Management
  • Sound knowledge of international GMP experience
  • In-depth knowledge of FDA specific regulatory requirements
  • In-depth knowledge in Inspection Readiness Procedures
  • In-depth Auditing experience
  • Team player and a communicative personality
  • Assertiveness and initiative is a must
  • Thorough and independent way of working
  • In-depth knowledge of documentation systems and computer skills.
  • Very good oral and written English skills
Start
keine Angabe
Dauer
8 months
Von
Randstad (Schweiz) AG
Eingestellt
03.05.2014
Projekt-ID:
702869
Vertragsart
Freiberuflich
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