Negotiable
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.