GMP QA Manager
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Hobson Prior are currently looking for a GMP QA Manager to join a brilliant biopharmaceutical organisation on a permanent basis located in Basel. Our client is focused on leveraging revolutionary technology to develop next-level remedies.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will be guarantee GXP compliance of contractors for API manufacture and testing, serving as the main point of contact for QA with CMO/CTO on set-up, aberrations and change assessment and batch evaluation.
- Offer advice on GMP to client groups in the organisation offering required oversight to guarantee compliance.
- Get acquaintance with company's drug product manufacture and packed stock release processes and guarantee QPs are made aware of any compliance concerns which could impact upon the safety of the organisation's clinical products.
- You will offer QA aid to validation actions at CMOs/CTOs.
- Familiarise self with the company products, technical agreements, regulatory reports, product specification files and subcontracted manufacturing chain.
- Preserve awareness of international GMP compliance needs for investigational products Biotech API and drug product manufacture, which involves the GCP interface.
- Establish self with company quality systems, such as partaking in their maintenance and ongoing improvement.
- Any other assigned duties.
- Comprehension of biologics drug substance and manufacturing procedure.
- Familiarity within aseptic manufacture of biologic DP and/or combination products would be ideal.
- Expertise on validation needs within a bio/pharma organisation.
- A high attention to detail.
- Capable of working within a busy and demanding setting.
- Communication skills both verbally and in writing.
- Able to resolve issues and think analytically.
- A motivated individual with the initiative to be proactive.
- Auditing abilities would be beneficial but not necessary for this role.
- Knowledge of the German language at a C1 level.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.
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