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Hyper Recruitment Solutions are currently looking for a QMS Lead to join a leading Pharmaceutical company based in the Cambridgeshire area. As the QMS Lead you will be responsible for ensuring the GMP Manufacturing operations on site comply with all relevant legislation and guidelines to maintain compliance.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QMS Lead will be varied however the key duties and responsibilities are as follows:
1. You will take an active role in designing and implementing a site audit plan, including maintaining an state of Audit Readiness. This will include hosting external inspections/customer audits and executing pre/post audit activities. The QMS lead will play a key role in CAPA implementation and administer the CAPA process.
2. The QMS Lead will maintain all on site risk and documentation management systems ensuring all relevant documentation is archived correctly. They will be required to maintain SME knowledge of relevant changes to legislation or regulatory guidelines.
3. You will write and prepare Quality Technical Agreements (QTA'S) and Product Quality Reviews (PQR'S) to maintain GMP compliance throughout the Supply Chain, ensuring CAPA's are implemented where needed.
4. Lead the generation and tracking of KPI's that feed into monthly reports to Senior Site management as well as identify and implementing continuous improvement opportunities within the Quality Systems Group and in the wider business.
To be successful in your application to this exciting opportunity as the QMS Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science or related subject
2. Proven industry experience in a Pharmaceutical QA role within a GMP compliant environment.
3. A working knowledge and practical experience with managing a GMP Compliant QMS would be advantageous.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.