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Senior Quality Assurance Officer

Recruit Right
Job LocationSouthport
EducationNot Mentioned
Salary£28,000 - £32,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Major Duties and Responsibilities

  • Quality Management System
  • Writing, reviewing and distributing Quality System Documents
  • Supporting master batch documentation (BMR/BPR/) review and issuance
  • Responsible for the review of commercial batches to include batch record approval, compliance to the product MA, and any deviations/changes approvals are completed ready for final release.
  • Batch release coordination integrating QC, Sales and external lab requirements.
  • assessment of impact, root cause, CAPA: impact of deviations on validated systems must be assessed from a validation perspective.
  • Generation, maintenance, and quarterly review and reporting of KPI’s across the QMS
  • Provide advice and guidance as required to help in meeting legislative requirements and Customer expectations.
  • Work within the Quality team to ensure that Customer projects are delivered to agreed quality standards and meet Customer specifications within agreed deadlines.
  • Deviation management - assessment of impact, root cause analysis, CAPA: impact of deviations. Champion meetings with required stakeholders/ Department heads to ensure that these issues are communicated out effectively and followed up on regularly, referringto QA manager.
  • Proven experience in a GMP Environment, within a Quality Assurance function.
  • Wide ranging and up to date technical knowledge and experience within the pharmaceutical industry.
  • A good track record with the MHRA, EMEA and other regulatory agencies, ideally with MHRA facing experience.
  • Overview and management of RSPO License, audits and completion of systems in place to monitor usage.
Knowledge and Experience:A Degree within a Life Science related field or equivalent industrial experience. Demonstrable experience working within QA/QC in the pharmaceutical industry. Demonstrable understanding of current regulatory requirements for the manufacture of licenced medicinalproductsExcellent scientific and technical knowledge
  • Quality Incidents & GMP Deviations (overseeing investigation, and review)
  • Out of Specification results, product investigation & review)
  • Customer Complaints (recording, investigating & review)
  • CAPAs (tracking and close out)
  • Change controls (instigating, review and approval)
  • Internal Audits (scheduling, performing and addressing findings with production/QC)
  • Training (undertaking or coordinating GMP training sessions and oversight of sitewide training matrix)
  • QA Review of Batch Manufacturing Records
  • Client liaison for Quality matters, including hosting customer audits.
  • Good understanding and working competency of Microsoft Excel

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