Quality Assurance Manager

vor 4 Wochen


Basel, Schweiz Randstad Vollzeit
Jobdescription
For our client, an international pharma company in Basel, we are looking for a motivated Quality Assurance Manager.

General Information:
 
  • Start date: 01.01.2025
  • Latest Start Date: 01.03.2025
  • Planned duration: Project planned until up to 3 years
  • Workplace: Basel
  • Workload: 80-100%
  • Home Office: up to 40% possible (Monday and Wednesday onsite days)
  • Team: about 15 team members
  • Working hours: Standard   

Tasks & Responsibilities:
 
  • End-to-end quality oversight on the qualified state of all assets in your assigned area.
  • Provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering.
  • Review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs.
  • Coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects.
  • With your operations partner you present topics during health authority inspections and internal audits.


Must Haves:
 
  • University degree in science or engineering
  • Min. 3 years demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site
  • Practical experience in commissioning & qualification projects in highly automated GMP production facilities
  • Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs
  • Your collaboration with partners is characterized by outstanding communication and team work.
  • You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.
  • Excellent German and English language skills, both written and spoken.


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