Role: QA Manager / Group Quality Manager- Pharmaceutical
Type: FTC 6 months
Salary: £35,000 - £40,000 DOE
Russell Taylor Group has a fantastic opportunity for a QA Manager to join a Pharmaceutical Company based within the North West of the UK. You will have experience working within the pharmaceutical industry, and furthered management experience. Would be an ideal opportunity for a Senior QA person to gain management experience or an existing Manager to gain furthered management experience in a GMP regulated environment.
Manage the Quality Assurance and Quality Control activities by ensuring that:
- GMP/UKAS standards are maintained and updated as necessary.
- Manufacturing procedures and SOP's are in place and updated as required
- Quality issues are logged and resolved in a timely manner
- Appropriate training is given to all members of the Quality Department
- Manage the Out of Specification and Deviations systems, ensuring appropriate actions are taken and investigations are conducted in a timely manner.
- To manage the validation activities (Cleaning, Equipment, process) and ensure they are undertaken as and when require against written and approved protocols
- To assist in the planning of the internal audit schedule and to conduct or co-ordinate the Internal audits to ensure the business is complying with GMP
- To work with the Lead auditor in ensuring all internal audits are clearly documented and all findings raised are fed back to the required departments for input into Root Cause and Corrective/Preventative Action (CAPA) identification
- Manage the production of the Product Quality Reviews at the required intervals.
- Review Medicinal product documentation before submission to the company contract QP's for batch release/certification.
- Participate in hosting external regulatory audits as required.
- To ensure all external regulatory audit findings are fed back to the relevant departments, all Root Cause and CAPA are appropriately assigned and all outcomes are communicated to the relevant external regulatory body within required timeframes.
- To monitor the progress and completion of all external regulatory audits and provide updates to higher management on a regular basis.
- Manage the "Complaints Procedure" and ensure that necessary actions are carried out in a timely manner.
- Will have a proved background in Quality Assurance a GMP regulated environment - acting in a QA based role (not QA Analytical).
- Will have experience in investigation tools CAPA / OOS and internal/external auditing experience.
- Will have worked in a senior QA capacity - training and mentoring other staff on the above activities.