Senior Associate QA

Proclinical is currently recruiting for a Senior Associate QA job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid Quality Assurance experience their team at their offices in Breda. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.

Job Responsibilities:

• Act as a first point of contact in case of production queries (quality related) during packaging and labelling operations.
• Work together with production and maintenance team to resolve the quality related problems.
• Review and approve class I Non Conformances
• Review and approve batch record exception reports
• Coach production and maintenance staff to improve on quality and to limit number of errors
• Perform finished product checks during (commercial) production runs
• Complete batch release preparation prior to Qualified person disposition.

Skills and Requirements:

• EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
• Preferably 0.5 year of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Manufacturing and/or Quality analytical processes and operations.
• Fluent in English language. Systems
• TrackWise (NC/CAPA)
• SAP
• MS Office (Word, Excel) Werum PAS-X (electronic batch Records) Skills
• Analytical
• Work independent
• Hands-on and result driven
• Team player
• Strong communication skills
• Excellent in English
• Quality mindset

To Apply:

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 Sam Walker on +44 203 8569 336 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.