QA Specialist, Pharmaceutical
Location: Bolton/ North Manchester area
Type: Permanent
Salary: £28,000- £30,000 DOE
Hours: Days (Monday - Friday), parking onsite
Additional: Annual performance bonus, health assured and company ran incentives
Our Client a Pharmaceutical company (part of a large Pharmaceutical group) is looking to strengthen their QA team. This is a perfect role for people with associated QA experience looking to move into a full-time QA role or people with QA experience to join a company very much on the up!
The Role:
- Fostering and promote Quality Compliance /GMP within the site and comply with
- company policies.
- Review Finished Batch Record and GMP Release for final QP Release.
- Support ongoing preparation for Regulatory License approvals.
- Oversee and input to QMS related Change Control, Non-conformance and CAPA
- Develop, Enhance and update the Quality Management System activities associated
- with the release of product, integrating as appropriate into central activities.
- Ensure appropriate maintenance of filing of Quality related documents, including
- Deviations and CAPA's.
- Maintain all QA databases which include but are not limited to QMS, master list,
- quality metrics, errors, daily orders, product enquiries and documents.
- Control and maintenance of Quality documentation, including generating, reviewing,
- issuing SOPs, forms and BMRs.
- Liaise with suppliers in order to obtain documents needed for Quality Approval such
- as leaflets, cartons and licenses.
- Documentation writing including reports, recording deviations, non-compliances and
- other quality related forms.
- Coordinate and manage to resolve customer complaints, recalls, change controls etc.
- ensuring proper root cause analysis and prompt responses/resolution.
- Reporting all deviations, complaints, change control and errors to seniors and QA
- Manager and carrying out quality investigations and QA closure.
- Support internal and external audits/inspection.
- Taking part in the internal audit programme to ensure continued GMP compliance of
- all site activities.
- Liaise with all departments to improve operations, quality of service and develop a
- positive progressive culture.
- Participate in training activities and maintain personal training records in an auditable
- state.
- Undertake any task, duties and responsibilities required by your Line manager with
- appropriate instruction and training.
The Person:
- Will hold a degree in a relevant - Scientific discipline or significant / relevant QA Pharma experience if no degree held
- Will have experience in CAPA, deviations, OOs, OOt, change-controls etc either directly or indirectly in a QA setting or similar (ideally Pharmaceutica/ GMP settings)
- Demonstrated compliance with procedures and policies
- Excellent team, interpersonal skills, and communication skills (both written and verbal)
_Important Information: _
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