QA Manager Drug Product
QA Manager Drug Product - Basel
Jocelyn Blackham is recruiting for a QA Manager Drug Product to join a company in the drug discovery industry at their site based in Basel on a contract basis of 12 months.
The main purpose of the role will be to:
- Provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards.
- Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs).
- Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team.
- Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation.
- Execute QA 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 to:
- 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.
- For assigned projects, ensure resolution of complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA).
- Notify management of potential quality and regulatory issues.
- Support the review and optimization of the company's pharmaceutical quality system by establishing 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.
- Excellent knowledge and experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or comparable operational positions in the pharmaceutical industry.
- Prior experience in quality assurance of drug product covering also combination products is essential.
- Provide GMP/GDP quality assurance expertise during development and later during commercialization.
- Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team.
This is an excellent opportunity to join a rapidly growing company in the pharmaceutical industry.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 782 516 595 or email jblackham@ckqls.ch. Please quote reference 46417 in all correspondence.
