Senior QA Officer PharmaceuticalsBased in London£32,000 £35,000 per annum + bonus + benefits Do you have experience working within Pharmaceutical QA / Quality Assurance?Would you...
QA Compliance Manager - Medical Device / Drug Delivery
Based in London
Salary c£50,000 + Excellent Benefits
Do you have extensive experience within a GMP or GxP environments?
Would you like to work for a successful, growing Pharmaceutical company?
My client are a specialist pharmaceutical company, with a strong development pipeline; due to continued growth they are looking to hire a QA Manager to take a lead role in the companies Quality Assurance and product quality. You will ensure GMP regulations are met during the drug development cycle, including IMP manufacture, device manufacture, product development, formulation, analytical and commercial manufacturing. The company manufactures on site and has a strong pipeline of products under development currently.
This role will oversee the QA Compliance Team.
Specific responsibilities will include;
- Provide leadership and support to the Quality Systems and Compliance Team through training, and coaching
- Maintain expert knowledge of the PQS, Policies, Procedures and site ways of working.
- Management and implementation of PQS systems and processes (i.e. Change Control, CAPA, Product Quality Complaints, Periodic Product Quality Reviews, Documentation and Risk Management) to ensure they follow company and regulatory standards
- Review and authorise company documents on behalf of the Quality Function, i.e. Policies, Procedures, validation documentation
- Drive Continuous Improvement activities to improve the PQS and promote a quality culture internally.
- Deliver the internal audit schedule, and ensure that compliance gaps are addressed through effective CAPA
- Deliver effective and timely KPIs to support site and group quality review processes to identify improvement opportunities
- Provide quality support for Regulatory and customer audits and support the resolution of any deficiencies in a timely manner to completion
- Build effective relationships with internal customers and external stakeholders
To be considered for the role you will need extensive QA experience, ensuring GxP compliance, of Pharmaceuticals. You'll need experience of CAPA Management and SOP Management, with previous experience of regulatory inspections and auditing. You'll also need people leadership experience.
This role would suit someone who is an excellent communicator, and likes a dynamic and interactive working environment. This is an excellent opportunity to join a forward thinking and growing pharmaceutical company.
Key Words "QA Manager, Quality Assurance Manager, Lead Auditor, GCP, GMP, Clinical Trials, Pharmaceutical Development, GxP, IMP Manufacture, QC, Pharmaceutical Product Development, formulation, CAPA, SOP"For more information and to apply, please call Neil Walton on 02030964706 or apply online.