Senior QA Specialist

Experience Dependent
15 Apr 2019
22 Apr 2019
Rhys Evans
Contract Type
Full Time
We are currently looking for a Senior QA Specialist to join a leading biopharmaceutical company based in the Hertfordshire area. As the Senior QA Specialist, you will be responsible for ensuring your team complies to GMP, GDP, and Environmental, Health and Safety requirements.


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

1. You will manage and provide oversight of the QMS, identifying any compliance gaps and implementing improvements as needed as part of the site's continuous improvement.

2. As the Senior QA Specialist, you will be the SME for deviations and their rectifications, supporting and advising as needed on the investigating of deviations and quality incidents, and, following on from this, the management of CAPAs and change controls

3. You will have line management duties over QA Officers through deputising for the Team Lead as needed. You will lead the training of QA Officers, identifying any training gaps and following up with completion of training required, and maintaining the training folders.

4. As the Senior QA Specialist, you will assist in the batch review processes, internal and external audits, and any projects on site. You will also lead the data integrity efforts across site.


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

1. Relevant Life Sciences degree.

2. Proven industry experience in operational QA within a sterile biopharma manufacturing environment.

3. A working knowledge and practical experience working to GMP, GDP and EHS requirements.

Key Words: QA / Quality Assurance / GMP / cGMP / GDP / EHS / Environment, Health and Safety / Compliance / Sterile Biologics / QMS / Quality Management Systems / Auditing / Audits / Training / Continuous Improvement / Deviations / CAPAs / Change Controls

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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