Proclinical is currently recruiting for a Quality Assurance III with a biopharmaceutical company located in Zug. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Oversee development and review department procedures.
- Ensure that department is audit ready at all times. Coordinates responses and CAPAs with stakeholders and auditor.
- Ensure department's processes and oversight meets contractual obligations with Partners
- Oversees QMS data analysis and metric reporting to applicable stakeholders
- Coordinate relevant vendor qualification and GxP audit management; support GxP audit follow-ups and CAPAs.
- Manage Quality Agreements with vendors, and monitors partner's performance against them, ensuring proper processes and procedures are implemented to meet company requirements
- Support and manage Change Controls.
- Ensure partner training documentation is developed and kept appropriately.
- Coordinate Biosimilar complaints and External Temperature Excursions
- Identify and drive the improvement of GxP processes and QMS in line with company direction.
- Ensure harmonization/integration of QMS to Quality/R&D QMS as appropriate
Skills and Requirements
- Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field)
- Minimum of 2-4 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology
- Experience in identifying deviations and CAPA
- Proficient in MS Word, Excel, Power Point and other applications
- Strong written and verbal communication skills
- Ability to communicate and work independently with scientific/technical personnel
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 James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com/send-cv
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.