Job Highlights
Not Disclosed
Entry level
Posted 1 year ago
Job details
Major Duties and Responsibilities
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 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.
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
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- United Kingdom
Experience:
- Entry level
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 16, 2024
Company Overview
Recruit Right Ltd
Current Openings: 0
At Recruit Right we believe in doing exactly that. We pride ourselves on our integrity and traditional recruitment values and we are determined and committed to providing exceptional levels of service. The Directors and Management team have over 65 years recruitment experience and are highly skilled in providing temporary and permanent recruitment solutions within the Industrial and Commercial sectors. We have an excellent reputation for providing a fresh approach to recruitment and offering a personal service to each of our clients and candidates. Recruit Right take as much care when recruiting our own consultants as we do when recruiting for our clients, because of this our consultants are highly experienced in recruiting within their specialist sector and they listen to and understand the needs of our clients and candidates. We recruit in the following sectors and are members of the Assoication of Labour Providers, REC and hold a gangmaster licence:- Food and Drink Manufacturing Warehouse and Distribution Onsite Managed Services Business Support Finance and Legal Sales and Marketing HR and Personnel Catering We have offices in Chester/North Wales,Edinburgh, London and the Wirral.
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