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Senior QA Specialist
Job Posted: 8 hours ago
Salary: £ Competitive
Job Type: Permanent
Location: Manchester, Greater Manchester
Expire in: a month
Job Description
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 advantageousJob 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 advantageousCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancyBefore You Apply
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