LOCATION: Portsmouth SALARY: Competitive REF: ALS 2551Apply Here
Our client, a contract testing organisation, is looking for an experienced quality assurance professional, to lead departmental and external audits, with responsibility for GMP compliance. This is a permanent role and a very exciting opportunity to shape your future.
Hours and days are flexible and salary is commensurate with experience.
- Excellent GMP compliance with experience across multiple projects
- Suitably qualified for this level of responsibility, preferably in scientific research
- Proficient in ISO 9001 with either manual or automated experience in QMS
- Demonstrable experience leading internal and external audits
- Good leadership capabilities
- Capable of providing sound advice on relevant quality matters.
- Confidence in client-facing responsibilities
- Able to manage and prioritise own workload effectively.
- Promotes a positive, cohesive, team-orientated environment.
- Experience in in vivo toxicology is desirable but not essential
Duties and Responsibilities
- Undertake the role of GMP Champion within the department, promoting quality management tools and coordinating best practice across the company.
- Contribute towards finalisation of new manual QMS, with responsibility for review and management
- Ensure departmental work meets internal quality assurance documentation and accepted published guidelines or sponsor protocols
- Ensure all relevant studies are carried out in compliance with GMP
- Provide quality assurance support to departments and clients
- Lead inspections of departments for compliance with GMP or other quality standards
- Host internal and external inspections, regulatory and clients, reporting to appropriate personnel
- Maintain the Company’s supplier approval procedures, inspecting vendors and sub-contract laboratories for approved supplier status.
- Enforce quality assurance review of change control documents, investigation reports associated with non-conformance/out of specification and any associated CAPA
- Conduct activities in accordance with site documents for H&S and quality systems.
- Review regulatory updates including USP/EP and ISO.
- Manage any DIRA reviews and process maps across the company.
- Supervise collation of data for the preparation of reports and for compliance with Quality Procedures for work performed in the department.
- Carry out GMP training of staff as required
Agenda only recruits people with integrity, who are honest and trustworthy and who have a great work ethic. To enable us to hire the very best people, we will conduct a comprehensive background and pre-employment screening, which is an essential part of Agenda’s recruitment process.