Tasks

- Ensure GMP compliance of the internal sterile facility, utilities, systems and equipment
- Manage, review and approve change controls, deviations and CAPAs related to the sterile pharmaceutical operations
- Manage, review and approve of qualification & validation documents of GMP equipment (facilities and utilities)
- Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation
- Provide relevant inputs on QA processes

Qualifications

- University degree, PhD or PharmD preferred
- Minimum of 8 years in sterile manufacturing and/or QA for steriles.
- Deep knowledge and understanding of sterile manufacturing process, quality control, packaging and distribution
- Excellent knowledge of relevant GMP/GDP and international quality regulations
- Ability to interpret and implement Q- standards
- Ability to manage complex projects and prioritize workload accordingly
- Ability to pro-actively initiate and lead quality compliance activities
- Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
- Fluent in English and at least basic knowledge of an additional European language, German or French advantageous