Address
Form of work
SalaryMajor 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, referring to 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 medicinal products
Excellent 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
