Job Details
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.
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.
