Job Descrption
Location: North London
Contract: Permanent
Salary: up to £28,000 + shift allowance
Shift Based
Do you have experience in reviewing documentation for batch release?
Are you looking for a challenging new role in the pharmaceutical industry?
Our client, is a leader in delivering high quality, processed biological materials, and is seeking a highly motivated and detail-oriented Quality Assurance Document Officer to join their dynamic team.
If successful, you will be responsible for reviewing and ensuring the completeness of batch records for final disposition, as well as working closely with manufacturing to resolve any discrepancies and support the timely release of batches.
Key responsibilities of the Quality Assurance Documentation Officer - Pharmaceuticals include:
• Act as the primary Quality Assurance point of contact for document review and batch release.
• Complete detailed GMP reviews and highlight any significant any concerns to supervisors.
• Conduct batch review... monitoring and maintain records in their Quality Management System.
• Assist in customer and regulatory audits
• Conduct reviews of the manufacturing process, assessing deviations and ensuring compliance
• Assess and review the process flow applicable to batch documentation and identify any non-conformances in the documentations.
• Understand and assess deviations and changes associated with batch review.
To be considered as a Quality Assurance Documentation Officer - Pharmaceuticals, you will need the following skills or experience:
• A BSc/MSc in a relevant scientific discipline or equivalent experience
• Previous experience in a clean room or manufacturing environment would be highly advantageous.
• Knowledge of sterile aseptic filling and packing manufacturing process.
• Demonstrable experience of working with quality documentation and Quality Management Systems.
• Prior experience of GMP.
• A willingness for continuous personal development with experience incorporating novel information into their working practices.
• Experience handling biological products and/or medical samples.
This is an excellent opportunity for a Quality Assurance Documentation Officer to join an enthusiastic and growing team, in order to take the next steps into your Quality career.
Please apply online or contact Victoria Body at CY Partners for more information.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
Keywords: “Batch Release, Quality Assurance, QA, GMP, Good Manufacturing Practice, GMP Compliance, Batch Records, Batch Documents, batch Release, Deviations, Quality Management Systems, QMS, London”
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