About Crescent Manufacturing
Crescent Manufacturing is part of the Crescent Pharmaceutical Group, an independent UK pharmaceutical business supplying generic medicines to the NHS and international markets. We hold an MHRA Manufacturer's Licence and operate to full EU GMP standards, manufacturing and packaging licensed medicines for Crescent Pharma and third-party Marketing Authorisation Holders.
We are a close-knit, hands-on team where quality is everybody's business. This is a role where you will see the whole picture – from raw material sampling on the production floor to the batch paperwork that lets a Qualified Person certify a product for release.
The role
You will support the Quality Manager and our Qualified Persons in maintaining and improving the site Quality Management System. The role is a genuine mix of desk-based QA and practical in-process work, so you will split your time between reviewing and compiling batch documentation and carrying out testing, sampling and monitoring within production.
What you will be doing
Batch documentation and release
- Review batch manufacturing, packaging and testing records for compliance with approved procedures and the product licence, and compile release packs for submission to the MAH
- Manage the archiving of QMS documentation, retained samples and batch release paperwork in line with company procedures and regulatory requirements
Quality systems
- Write and review Deviation Reports, investigations and CAPAs, and report outcomes to the MAH
- Investigate customer complaints and report findings back to the MAH
- Ensure changes are raised through Change Control and fully implemented, with all supporting activities completed
- Support regulatory variations by preparing data packages and reports
- Help maintain the site Documentation System, and write and revise SOPs covering GxP activities
- Prepare Product Quality Review (PQR) reports
- Create, review and approve validation protocols and reports (process, analytical, equipment and systems)
- Record and report Quality department KPIs
Audit and inspection
- Take part in the internal audit programme
- Support audits of Crescent Manufacturing suppliers and sub-contractors, in the UK and overseas
- Support MHRA and customer inspections of the site
In-process quality (production floor)
- Perform periodic in-process checks within the production department
- Sample raw materials
- Carry out environmental monitoring
General
- Deliver GxP training as requested, in line with internal training policy
- Contribute to project work and continuous improvement initiatives
- Plan and prioritise your own workload to meet agreed timelines and departmental objectives
Who you will work with
- Internally: QA, Production, Supply Chain and Planning, Customer Services and Warehouse teams
- Externally: Marketing Authorisation Holders and QP consultants
What we are looking for
Essential
- Degree (or equivalent) in a scientific discipline – Chemistry, Pharmacy, Biochemistry, Microbiology or Biology preferred
- Good attention to detail and the discipline to follow defined procedures and regulatory guidelines
- Self-motivated and well organised, able to work on your own initiative and as part of a team
- Effective time management and a flexible approach to shifting priorities
- Strong interpersonal and written communication skills
- Confident with Microsoft Office (Excel, Word, PowerPoint, Outlook)
Desirable
- 5 years Experience in a GMP-regulated pharmaceutical environment (QA, QC or production)
- Working knowledge of EU GMP, deviation and CAPA management, or validation
- Familiarity with electronic QMS or document management systems
What we offer
- £30,000 - £35,000
- 25 days Holiday Entitlement
- Broad exposure across the full GMP quality lifecycle at an owner-led, growing pharmaceutical group
How to apply
Please send your CV and a short covering note to [email / application link]. We review applications as they arrive and may close the advert early if we find the right candidate.
How we handle your data
CVs submitted in response to this advert will be shared with relevant staff within the Crescent Group for shortlisting. Your CV may be retained on our system until the vacancy is filled. If you attend an interview, any interview notes or test results will be retained alongside your CV as part of your personnel record should you join us. If you are not offered a position, these records will be deleted six months after the campaign closes, in line with our retention policy.
You have the right to access, rectify and restrict processing of your personal data, and in some cases to request erasure or data portability. To exercise these rights, please contact us via the Contact Us page on our website, quoting "Personal data" in the subject line.
Job Types: Full-time, Permanent
Pay: £30,000.00-£35,000.00 per year
Benefits:
- Free parking
- Life insurance
- On-site parking
Experience:
- Quality Assurance: 4 years (preferred)
Work Location: In person
