Quality Operations Associate

CK Group; Hatfield; On-site; GBP 35,000 - 45,000; Full time

Job summary

A global pharmaceutical company is seeking a Quality Operations Associate in Hatfield on a fixed-term contract covering maternity leave. The role involves supporting Quality Systems and Assurance activities, ensuring GMP compliance. The ideal candidate should possess effective relationship skills, knowledge of Quality Systems, and good technical judgement. Responsibilities include supporting Quality processes and assisting in audits and investigations.

Qualifications

• Ability to establish and maintain effective working relationships.
• Basic knowledge of Quality Systems and Quality Assurance.
• Good technical and scientific judgement.
• Ability to interpret complex data.
• Computer literacy, including Word, Excel, and PowerPoint.
• Basic understanding of GMP Guidelines.

Responsibilities

• Support operational Quality Management System processes.
• Act as the Quality point of contact for production and operational departments.
• Review and approve batch records and documentation.
• Assist in audits and investigations of incidents.
• Support technology transfers and new product introductions.
• Identify cost-saving and efficiency improvements.

Skills

Establishing effective working relationships

Basic knowledge of Quality Systems

Good technical and scientific judgement

Interpreting complex data

Computer literacy (Word, Excel, PowerPoint)

Understanding of GMP Guidelines

Job description

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.

Overview

Supports Quality Systems and Assurance activities, ensuring GMP compliance and effective QMS implementation across manufacturing, packaging, testing, storage, and distribution of drug products.

Responsibilities

• 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 [e-mail]. Please quote job reference 153 649 in all correspondence.

INDLS