Audit Manager Sr ensuring quality assurance in internal audit engagements at PNC. Reviewing internal audit engagements and implementing quality assurance initiatives for compliance with IIA standards.
About the role
- QA Manager responsible for pharmaceutical client's compliance and quality assurance at manufacturing site. Focus on regulatory requirements and quality system development in the pharmaceutical sector.
Responsibilities
- Responsible oversight of selected customers and their products at the site
- Preparation and creation/modification of specifications for active pharmaceutical ingredients and medicinal products
- Review of regulations for pharmaceutical manufacturing and of process validation documents
- Preparation, assessment & coordination of pharmaceutical product changes (Change Control) in line with current guidelines and customer requirements
- Handling of quotations/requests, e.g., for new products or changes
- QA support for development activities related to the introduction/transfer of medicinal products
- Preparation and coordination of quality assurance agreements with customers and API suppliers
- Preparation of Product Quality Reviews
- Handling requests from Global Regulatory Affairs for the Zwickau site
- Participation in audits and inspections (including internal/self-inspections)
Requirements
- University degree in Pharmacy, a natural science, or a comparable qualification
- At least 2 years' experience in the pharmaceutical sector (Quality Assurance)
- GMP knowledge related to the manufacture, quality and approval of medicinal products
- Good knowledge of GMP regulations and current legislation (e.g., German Medicines Act – AMG, AMWHV)
- Above-average commitment, assertiveness, team spirit, strong communication skills and a service-oriented approach
- Very good written and spoken English
- Confident user of MS Office
Benefits
- Appreciative, collegial cooperation and scope to implement ideas
- Competitive, performance-based remuneration according to the company pay agreement
- Permanent full-time position with 38.5 hours per week; 31.5 days annual leave
- Holiday pay, annual special payment and health-promoting employee offers
- Additional benefits such as employer-funded pension provision and corporate health insurance
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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