QA Manager leading and developing QA team to ensure high quality standards for AI solutions at Expert.ai. Responsible for planning and integrating QA practices in the software development lifecycle.
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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