Quality Assurance Representative Job in Merseyside, North West Uk
A Quality Assurance Representative is required for leading global pharmaceutical company who manufacture human and animal health care products which enhance wellness and performance.
The Quality Assurance Representative will report to the Quality Assurance Group Leader and will provide the Quality Assurance Team the assurance that manufacturing is carried out in accordance with cGMP and Regulatory commitments and that production records provide full and accurate documentation of batch manufacture in accordance with SOP.
The QAR is authorised, as appropriate, by the QA Team Leader to disposition materials with consideration being given to the Regulatory requirement for QP release of veterinary and medicinal products.
The job holder also exercises control on the general cGMP activities for those teams he/she has QA responsibility for.
• Disposition raw materials, including packaging items, water, intermediates and products according to the available data, including evaluation of any deviation reports, environmental monitoring (where appropriate), and advise on reprocessing or preventive actions in such cases.
• Monitor trends and identify problems in quality of purchased materials, packaging, intermediates, products, water and environmental data and promote action having regard to changes in processes, facilities, equipment and procedures.
• Write/revise/approve and give advise on quality documentation e.g. batch production records, specifications, procedures (Team and Site), PMIS sheets, Stability protocols.
• Review and approve SOPs (Team and Site), change control documentation, validation protocols, completed validation packages, IQ/OQ/PQ protocols.
• Manage the Site stability programme to meet Corporate and Regulatory requirements.
• To advise on the investigation of customer complaints, approve customer complaint reports and promote corrective/preventive actions
• Participate in self-inspections and other audits of the manufacturing and relevant Support areas with particular reference to cGMP as defined by the various regulatory authorities.
• Provide training, support, advice and proactive assistance in the Site Quality systems to the product and support teams.
• Advise on and support appropriate validation of plant, processes and new projects, liaising with other disciplines appropriately to ensure that facilities are designed and commissioned to meet cGMP.
• Provide cover for other QARs in their absence.
• Prepare Quality Agreements as appropriate.
• Liaise with Contract Manufacturers, as appropriate, to ensure that the Quality systems at the Contract Manufacturers comply with Corporate/Regulatory requirements and that the Quality systems are being implemented appropriately.