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Senior QA Specialist

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Job Description - Senior QA Specialist

Job Title: Senior QA Specialist
Salary: £38,000 - £45,000
Location: Greater Manchester


SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for an experienced QA Manager to join them and take ownership over the QMS.

Typical responsibilities/accountabilities:

  • Work with Qualified Person to enable the efficient evaluation and release of IMP to clinical studies on clients' behalf.
  • To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc.
  • Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the approval and maintenance of the site MHRA MIA (IMP) licence.
  • To ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.
  • To oversee compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc.


Essential Requirements:

  • Degree or equivalent qualification in a life science or similar subject
  • Extensive recent experience of QA leadership in a Pharma/CMO company.
  • Proven track record in supporting QP release.
  • Excellent knowledge of global regulations, and experience of dealing with MHRA.
  • Good communication skills internally and in a client facing role.
  • Experience of early-phase product development and IMP manufacturing would be highly advantageous

Job Title: Senior QA Specialist
Salary: £38,000 - £45,000
Location: Greater Manchester


SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for an experienced QA Manager to join them and take ownership over the QMS.

Typical responsibilities/accountabilities:

  • Work with Qualified Person to enable the efficient evaluation and release of IMP to clinical studies on clients' behalf.
  • To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc.
  • Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the approval and maintenance of the site MHRA MIA (IMP) licence.
  • To ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.
  • To oversee compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc.


Essential Requirements:

  • Degree or equivalent qualification in a life science or similar subject
  • Extensive recent experience of QA leadership in a Pharma/CMO company.
  • Proven track record in supporting QP release.
  • Excellent knowledge of global regulations, and experience of dealing with MHRA.
  • Good communication skills internally and in a client facing role.
  • Experience of early-phase product development and IMP manufacturing would be highly advantageous

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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