Head of Quality, Pharmaceutical
Location: Stevenage Type: Permanent Hours: Days (onsite) Mon - Friday Salary: c£80,000 DOE (salary can be discussed)
Russell Taylor Group LTD is working with a leading Pharmaceutical company who is looking to appoint an experienced Head of Quality (HOQ). The HOQ will manage both QC & QA teams (x14 in the team/s).
The Role:
Managing the QMS to ensure compliance with UK and EU pharmaceutical legislation and other applicable legislation as required to meet country standards of product use. Managing relationships with authorities such as the MHRA and the BRC and with the company's customer base. Maintaining and growing regulatory knowledge for self and the team required to sign off and maintain key relevant documentation. Developing and implementing appropriate compliance practice, cost-effective and robust processes, operating principles and guidelines throughout the Quality Organisation and its associated responsibilities. Acting as a mentor to the Quality team, nurturing, developing and coaching the team/s to also act as coaches for improved compliance performance across the site. Leading and implementing planned change within the Site Quality function. Maintaining operational continuity both internally and with that of the customer base managing resources as required. Keeping up to date with changing compliance expectations from regulatory bodies and customers, adapting and improving quality systems as required. Driving and supporting the improvement of manufacturing processes robustness through continuous improvement and high-quality CAPA generation. Obtaining high customer satisfaction ratings relating to quality, delivery and service from the Business development/Sales teams to support customer requests. Overseeing and improving all key quality activities including: Product release, PQR preparation and issue, Stability, Validation, Regulatory Licence product maintenance, Audit and API conformance, QC Testing, Customer complaint and interface, Technical Agreements, Regulatory Audits, Supply base audits and conformance, Calibration/PPM, Warehousing, Documentation approval and control. Liaising with Technical functions to improve processes after deviation, change control or CAPA activities.
The Person: Will ideally hold a degree in a relevant STEM related subject (or have vocational qualifications/on the job experience). Extensive experience within a senior quality role/GMP setting. Experience in managing both QA and QC functions. Strong knowledge of H&S systems. Strong management experience with a history of improving team performance. Experience in audit hosting, audit management etc. QMS implementation and preservation experience. Experience in supplier auditing. Experience dealing with the MHRA and/or BRC authorities.
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Location: Stevenage Type: Permanent Hours: Days (onsite) Mon - Friday Salary: c£80,000 DOE (salary can be discussed)
Russell Taylor Group LTD is working with a leading Pharmaceutical company who is looking to appoint an experienced Head of Quality (HOQ). The HOQ will manage both QC & QA teams (x14 in the team/s).
The Role:
Managing the QMS to ensure compliance with UK and EU pharmaceutical legislation and other applicable legislation as required to meet country standards of product use. Managing relationships with authorities such as the MHRA and the BRC and with the company's customer base. Maintaining and growing regulatory knowledge for self and the team required to sign off and maintain key relevant documentation. Developing and implementing appropriate compliance practice, cost-effective and robust processes, operating principles and guidelines throughout the Quality Organisation and its associated responsibilities. Acting as a mentor to the Quality team, nurturing, developing and coaching the team/s to also act as coaches for improved compliance performance across the site. Leading and implementing planned change within the Site Quality function. Maintaining operational continuity both internally and with that of the customer base managing resources as required. Keeping up to date with changing compliance expectations from regulatory bodies and customers, adapting and improving quality systems as required. Driving and supporting the improvement of manufacturing processes robustness through continuous improvement and high-quality CAPA generation. Obtaining high customer satisfaction ratings relating to quality, delivery and service from the Business development/Sales teams to support customer requests. Overseeing and improving all key quality activities including: Product release, PQR preparation and issue, Stability, Validation, Regulatory Licence product maintenance, Audit and API conformance, QC Testing, Customer complaint and interface, Technical Agreements, Regulatory Audits, Supply base audits and conformance, Calibration/PPM, Warehousing, Documentation approval and control. Liaising with Technical functions to improve processes after deviation, change control or CAPA activities.
The Person: Will ideally hold a degree in a relevant STEM related subject (or have vocational qualifications/on the job experience). Extensive experience within a senior quality role/GMP setting. Experience in managing both QA and QC functions. Strong knowledge of H&S systems. Strong management experience with a history of improving team performance. Experience in audit hosting, audit management etc. QMS implementation and preservation experience. Experience in supplier auditing. Experience dealing with the MHRA and/or BRC authorities.
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