QA Specialist

Experience Dependent
14 May 2019
11 Jun 2019
Rhys Evans
Contract Type
Full Time
We are currently looking for a QA Specialist to join a leading gene therapy company based in the Hertfordshire area. As the QA Specialist, you will be responsible for ensuring compliance to GMP and GCP standards, and lead the batch manufacturing activities.


Your duties as the QA Specialist will be varied. However, the key duties and responsibilities are as follows:

1. You will lead batch manufacturing activities, reviewing and issuing BMRs and labels, facilitating batch disposition in conjunction with the QP and the release of raw materials cross-functionally.

2. As the QA Specialist, you will liaise with third party manufacturers and providers in the management of Quality Technical Agreements and the maintenance of Product Specification Files

3. You will manage deviations, quality investigations, CAPAs and change controls, and review and approve shipment temperature data, SOPs, validation protocols and reports.

4. As the QA Specialist, you will ensure GMP and GCP compliance through leading internal audits, trending and tracking quality metrics and KPIs.


To be successful in your application to this exciting opportunity as the QA Specialist, we are looking to identify the following on your profile and history:

1. Relevant Life Sciences degree.

2. Proven industry experience working with Investigational Medicinal Products within Quality Assurance in a GMP environment.

3. A working knowledge and practical experience with Advanced Therapy Medicinal Products and Quality Assurance in a GCP environment.

Key Words: QA / Quality Assurance / ATMP / Advanced Therapy Medicinal Products / IMP / Investigational Medicinal Products / cGMP / GMP / Good Manufacturing Practice / GCP / Good Clinical Practice / Compliance / BMR / Batch Manufacturing Record / Batch Release / QTA / Quality Technical Agreement / PSF / Product Specification File / Deviation / CAPA / Change Control / SOP / Validation Protocol / Audit

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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