CK Group are recruiting for a Quality Operations Associate
with a well-established and successful global pharmaceutical Company, based in Hatfield, Hertfordshire, on a fixed term contract basis covering maternity leave.
Role:
Supports Quality Systems and Assurance activities, ensuring GMP compliance and effective QMS implementation across manufacturing, packaging, testing, storage, and distribution of drug products.
Key duties will include :
* Support operational Quality Management System processes, including Product Quality Reviews, Quality Agreements, Change Control, Risk Management, Deviations, Training, Documentation, Audits, and Supplier Management.
* Act as the Quality point of contact for production and operational departments.
* Review and approve batch records, master batch records, SAP material data, QC documentation, and SOPs.
* Assist in audits, regulatory inspections, and investigations of incidents, deviations, CAPAs, and customer complaints.
* Support technology transfers, new product introductions, and GDP activities.
* Represent Quality Operations on risk assessments, focus teams, and continuous improvement projects.
* Identify and implement cost-saving and efficiency improvements in quality processes.
Your Background:
* Ability to establish and maintain effective working relationships and communication links with affiliated organisations and other customers
* Basic knowledge of Quality Systems, Quality Assurance, GMP and basic understanding of manufacture and packaging of pharmaceutical products
* Good technical and scientific judgement
* Ability to interpret complex data and present key findings
* Computer literate e.g. Word, Excel and PowerPoint
* Basic understanding of GMP Guidelines and Regulations
Apply:
It is essential that applicants hold entitlement to work in the UK. For more information or to apply for this position please contact Anastasia Allen on 01246 457737 or email aallen@ckgroup.co.uk Please quote job reference 153 649 in all correspondence.
INDLS