Hobson Prior are currently looking for a QA Manager to join a growing biopharmaceutical company in Switzerland, who focus on discovering, developing and bringing more pioneering medicines to patients.
- Deliver GMP/GDP expertise 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.
- Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team.
- Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation.
- Perform 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.
- 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.
- Ensure resolution of complaints, testing issues, discrepancies, Out of Specifications and Corrective and Preventive Actions.
- Support the review and optimization of the company’s pharmaceutical quality system by establishing relevant Key Performance Indicators.
- Strong interpersonal and influencing skills.
- Excellent verbal and written communication skills in English.
- Ability to manage multiple tasks with competing priorities.
- A minimum of 5 years’ 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.
- A minimum of 3 years’ experience in quality assurance of drug product covering also combination products.
- A strong understanding of GMP and GDP requirements, ability to interpret and implement quality standards.
- Sound knowledge of drug product manufacturing, control, packaging and distribution procedures.
- Experience in SAP required.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.