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.