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Gmp Lead Auditor

vor 2 Wochen

Zurich, Schweiz Panda International Vollzeit

**GMP Lead Auditor**:
**Location**
- Zurich, Switzerland

**Business Sector**
- Biotechnology

**Job ref**
- 22275

**Published**
- 6 days ago

Our client, a leading biotech company based in Switzerland, is actively seeking a highly experienced and detail-oriented GMP Lead Auditor to join their Quality Assurance team. This role is instrumental in ensuring compliance with Good Manufacturing Practice (GMP) regulations and maintaining the highest standards in their manufacturing processes.

**Key Responsibilities**:

- Develop and execute risk-based GMP audit plans for manufacturing facilities, ensuring comprehensive coverage of critical processes and systems.
- Prepare detailed audit reports summarizing findings, observations, and recommendations for corrective and preventive actions (CAPA).
- Work closely with manufacturing, quality control, and regulatory affairs teams to assess GMP compliance and provide guidance on corrective actions.
- Identify opportunities for process improvement and contribute to the development and enhancement of GMP quality systems.
- Interface with regulatory authorities during inspections, addressing audit-related queries and ensuring a seamless audit experience.
- Provide GMP training to internal stakeholders, fostering a culture of awareness and compliance with GMP regulations.
- Conduct thorough reviews of manufacturing documentation, ensuring accuracy, completeness, and compliance with GMP standards.

**Qualifications**:

- Bachelor's or Master's degree in a relevant scientific discipline.
- Extensive experience in GMP auditing within the biotech or pharmaceutical industry.
- In-depth knowledge of GMP regulations, international quality standards, and applicable regulatory requirements.
- Strong understanding of biotech manufacturing processes.
- Excellent communication and interpersonal skills.
- Certification as a Lead Auditor is highly desirable.

?: +41 (0) 44 5514 407