Description
Quality Assurance Representative
Pharmaceutical
Merseyside
Contract - 6 months +
Competitive Daily Rates
Job Purpose:
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To provide the QA Team to assurance that manufacturing is carried out in accordance with cGMP and regulatory commitments for external contract manufacturers.
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To be 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.
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The job holder also exercises control of general cGMP activities for those teams he/she has QA responsibility for.
Responsibilities:
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Ensure that the Quality systems at the Contract Manufacturers comply with Corporate/Regulatory requirements and that the Quality systems (deviations, change controls, complaints etc.) are being implemented appropriately through continuous oversight
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Ensure cGMP compliance through execution of the approved Quality Agreement with Contract Manufacturers and provide advice on continuous quality improvement aspect
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Monitor trends and identify problems in quality of purchased materials, packaging, intermediates, finished products, water and environmental data and promote corrective/preventative actions
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Write/revise/approve and give advice on quality documentation eg batch production records, specifications, procedures (internal/external), stability protocols and reports, change controls, deviations, complaints, annual product reviews, quality agreements, validation protocols and completed validation packages
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Advise on and support appropriate validation of plant, processes and new projects, liaising with other disciplines appropriately to ensure that facilities, utilities and equipment are designed and commissioned to meet cGMP
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Support the disposition raw materials, including packaging items, intermediates and finished 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
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Support and participate in Contract Manufacturer corporate audits and other relevant support areas with particular reference to cGMP as defined by the various regulatory authorities
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Provide training, support, advice and additional QA assistance within the QA team
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Monitor and support the Contract Manufacturer stability programme for products to meet corporate requirements and ensure any out-of-specifications are investigated in a timely manner.
Essential requirements:
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A Degree in a Scientific (BSc/BSc (Hons) minimum or equivalent) or Engineering discipline with experience in a pharmaceutical cGMP environment
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Pharmaceutical QA experience
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Proven problem solving methodology/skills for complex technical issues.
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Proven ability to understand and interpret process/analytical data.
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Multi-tasking and priority/time management skills are essential.
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Excellent interpersonal skills with the ability to work as an individual or as part of a close working team and delivering on business objectives.
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Build relationship with direct team members as well as external partners to ensure full collaboration and influence is essential.
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Confident in team environment to contribute and challenge the status quo and take a technical stand when required - can present technical information to senior management in a clear and concise manner.
Experience:
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Good understanding and knowledge GMP and QA in a pharma environment
Desirable requirements:
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Experience in a pharmaceutical cGMP manufacturing environment.
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Technical transfer or project management of production processes at manufacturing scale is desirable.
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Flexibility in travel to support business deadlines and customer requirements (likely to be restricted in Western Europe with one/two days away only).