Scientific QA Manager (GDP/GMP)
- Experience Level
Our global pharmaceutical client has a vacancy for a QA Manager (GDP/GMP)
Our client is looking for candidates based in Switzerland/ EU.
This is an initial 12-month full time contract.
- Provide GMP/GDP quality assurance expertise during development and commercialization of products
- Ensure all required quality activities are initiated and completed according to the development stage with advice from management
- Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards with advice from management.
- Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle, with advice from management
- Participate, represent and defend quality activities in CMC team meetings
- Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team, with advice from management
- Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation
- University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
- 3-6 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
- 3-6 years of experience in quality assurance of drug substance and/or drug product
- Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
- Good knowledge of (c)GMP/GDP’s