QA Manager Position!
Company: Advanced Clinical Recruitment Ltd
Reference: QAM- Joe F
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Salery, enhanced pension scheme, 25 days holiday, Great opportunity for career progression
A well known global organisation are looking for a Quality Assurance Manager to join their vastly growing team based in Central London!
- To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD expectations.
- Provide GCP, MDD and regulatory expertise, guidance and training for the company.
- Implementation and maintenance of all aspects of the Quality System and SOP life cycle including; process development, review, implementation, training, monitoring of process compliance.
- Updating and maitaining the Quality manuel online and implementation and maintenance of the QA and Compliance Strategy.
- Take ownership of the internal and key suppliers auditing schedule and entirety of the process as well as hosting and managing audits and regulatory inspections.
- Identify those areas of quality processes that need to be improved and propose new ways to improve quality of the organisation while maintaining those processes and systems that are working.
- Ensuring that the quality system is established, implemented, maintained and monitored in accordance with the relevant standards.
- Reporting into the senior manager once a month of the quality and regulatory metrics and possible issues and progressivly resolving these issues.
Required Skills and Experience
- Have 5 years experience as a quality professional in the pharmaceutical regulatory environment, and has held a Quality / Regulatory position.
- Experience with large pharmaceutical companies and CROs is desirebale.
- Extensive experience of definition and maintenance of Quality Management Systems, audit planning and management and the clinical trials process.
- Excellent understanding of GCP and clinical trials regulation and compliance requirements.
- Experience of managing external (client) audits and regulatory inspections.