Hannah Milward is currently recruiting for a Quality Assurance Representative to join a global manufacturer of pharmaceutical and veterinary medicine products based in the Merseyside region. They require a Contract Quality Assurance Representative to join their team for an initial period of 12 months.
Job Purpose:
The successful candidate for this Quality Assurance Representative 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.
Responsibilities:
The responsibilities of this Quality Assurance Representative role will include:
• 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), PMISsheets, 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.
Qualifications and skills:
To be considered for this Quality Assurance Representative position you will have experience working in a similar role reviewing and supplying batch record documentation to the QP for release. You will also have experience working in the Pharmaceutical industry.
How to apply:
For more information or to apply for this Quality Assurance Representative role please contact Hannah Milward on 0114 2839956 or email hmilward@ckscience.co.uk. Please quote reference SH23570 in all correspondence.
