ProClinical is seeking a QA Manager Manufacturing for one of the most rapidly growing biotechnology companies in Europe, who are working on revolutionary approaches in the fight against cancer and other diseases. Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths - and ensure people all around the world have hope for the future.
- Together with your team colleagues (m/f), you will set up and continuously improve a broad-ranging pharmaceutical quality management system for the areas of GCLP, GMP and GCP.
- You will also prepare, review, approve and revise regulatory documents (such as SOPs, plans, reports, manufacturing specifications) and assist in preparing PQRs.
- Moreover, you will help set up GMP-compliant production and provide quality assurance supervision in routine production in clean rooms.
- You will also be responsible for overseeing hygiene and monitoring measures in the production process.
- Finally, you will provide regulatory supervision in production and storage.
Skills and Requirements:
- Degree in natural sciences or completed vocational training as a biology lab technician, BTA, MTA, PTA, CTA (m/f) or equivalent qualification
- In-depth knowledge of the relevant rules in the biotechnology/pharmaceutical industry (especially GCLP, GMP and GCP)
- Practical experience in quality assurance/quality management or manufacturing
- Relevant experience in the routine manufacturing of sterile dosage forms
- Reliability, capacity for teamwork and organisational talent. Confident handling of MS Office. Very good English skills, both written and spoken
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.