Senior QA Officer
Senior QA Officer
I am currently working with an exciting Pharmaceutical company in Cambridge who are looking for a Senior QA Officer to join the team.
The purpose of this Senior QA Officer role is to oversee and support the overall quality and compliance activities during the product development life cycle processes and to ensure quality oversight of our CMOs during product development including manufacturing, testing activities, and also supporting the release of Investigational Medicinal products for our company.
Senior QA Officer Responsibilities:
- Oversee suppliers and third-party vendors to ensure compliance with company and GMP standards.
- Prepare Quality Agreement with new 3rd party / contract organisations as required by the development team.
- Investigate complaints/manage deviations and out-of-specifications.
- Perform and reviews related change controls and CAPA's.
- Assist in audits to ensure compliance to SOPs, GMPs and applicable regulations
- Support review and approve CMC and non CMC related documents, including product specification, batch documentation, CofAs, stability data, test method, analytical validation report, method transfer, process validation protocol and reports and packaging documentation, to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification
- Support clinical supplies / pilot batches activities, including providing approval and release for clinical supplies / pilot batches and registration samples.
Senior QA Officer Requirements:
- Minimum of five years of pharmaceutical experience in R&D QA, supporting the GMP manufacture of investigational medicinal products.
- Experience in solid dosage forms is preferred
- Experience in Quality Assurance in pharmaceutical GMP environment is required
- Proficiency in cGMPs, and other regulatory guidances
If this Senior QA Officer role looks as though it could be the next step in your career, please get in touch as soon as possible!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales