Quality Operations Associate

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.

• 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

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