QA Manager Drug Substance
Jasmin Baumgartner is recruiting for a Senior QA Manager Drug Substance (GMP/GDP) to join a rapidly growing company in the drug discovery area. The position will be offered on a 12 month contract at our clients site in Basel, with the possibility of extension.
The main purpose of the role will be to:
- Provide GMP/GDP quality assurance expertise during development and later during commercialization of products.
- Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs).
- Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team.
- Write, review, and/or approve internal SOPs and other GMP/GDP related documentation.
- Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards.
- Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle.
- Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls.
Further responsibilities will include:
- Notifying management of potential quality and regulatory issues.
- Providing guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed, on assigned projects.
- Supporting the review and optimization of the company's pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree.
- Previous experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry.
- Previous experience in quality assurance activities specific to drug substance.
- Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards.
- Strong interpersonal and influencing skills.
- Entrepreneurial mind set combined with cost consciousness.
This is an excellent opportunity to join a expanding pharmaceutical company.
For more information or to apply for this position, please contact Jasmin Baumgartner on 0041 (0) 782 508 535 or email jbaumgartner@ckqls.ch. Please quote reference 46585 in all correspondence.
