Quality Assurance Project Manager for Pharma

Vor 5 Tagen

Bern, Schweiz agap2 - HIQ Consulting Vollzeit

Founded in 2005, agap2 is a European company of engineering and operational consulting. We operate in the sectors of Energy, Infrastructure, Transport, Chemistry, Life Sciences and IT. Today, the agap2 group has a team composed of over 5000 qualified doctors and engineers. We work on projects around the world from our offices in Europe - Switzerland, Germany, Belgium, Spain, France, Netherlands, Portugal, and UK. We attach as much importance to the spirit, ambition, dynamism, and daring as to the expertise of our teams. Attached to these basic human values, we recruit high-value profiles to strengthen our technical teams and our industrial partners in Switzerland (offices in Basel, Zurich and Lausanne).

Tasks
- Ensure that products, systems and equipment are in sustainable compliance with GMP and regulatory requirements.
- Ensure efficient and effective quality assurance activities at the required GMP level.
- Responsible for all documentation associated with the area of quality, pharmaceutical standards and norms.
- Review and approve SOPs and other quality related documents.
- Review and approve raw materials.
- Review and evaluate global change controls.
- Review and approve event and deviation reports. Evaluate event and deviation reports to determine if they need to be forwarded to the Quality Development Manager.
- Ensure appropriate and effective CAPAs are defined with appropriate timelines and ensure timely implementation.
- Ensure appropriate coverage of CAPAs with effectiveness checks, monitor their execution and evaluate results.
- Review and approve certifications for health authorities.
- Support the compilation of PQRs.
- Improve understanding of GMPs through team training
- Support the inspection team during the preparation, execution and follow-up of inspections and audits.

**Requirements**:

- Msc or Phd with a first experience in Pharma Industry (GMP)
- Proven Experience in Management of deviations, Redaction CAPAs, Change controls and risk analysis
- English and German spoken and written.
- Analytical thinking and problem-solving skills.
- Communication skills and good negotiation skills.
- Excellent interpersonal and team collaboration skills.

**Benefits**:
At agap2 you will work with a Technical Manager at your side who will follow, support and prepare you for next steps in your career. In addition, you can expect work in a friendly and dynamic team, extensive development opportunities and growing responsibilities.

Applications from Switzerland and EU only will be considered.

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