Scientific QA Manager (GDP/GMP)
Jocelyn Blackham is recruiting for a Scientific QA Manager (GDP/GMP) to join a company in the pharmaceutical industry at their site based just outside of Basel on a contract basis for 12 months.
Scientific QA Manager (GDP/GMP) role:
- Provide GMP/GDP quality assurance expertise during development and commercialization of company's products
- Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards with advice from management
- For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed, with advice frommanagement
- 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
Further responsibilities will include:
- Participating, representing and defending quality activities in CMC team meetings
- Assisting GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs) on demand
- Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- MSc inPharmacy, Chemistry or alternative technical/science university degree, or above
- Previous experience inexperience 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
- Fluent in English and at least basic knowledge of an additional European language, German or French advantageous
This is an excellentopportunity to join a growing pharmaceutical company at their site just outside of Basel.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote reference 50236 in all correspondence.