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Job type: Permanent

Discipline: Good Distribution Practice (GDP)

Location: United Kingdom

Keep the heartbeat of innovation running! Join our client in this QA Operations position and ensure cutting-edge pharma operations never miss a beat!

��Ƶ is seeking a QA Associate Operations to support quality systems and assurance activities related to the manufacturing, packaging, testing, storage, and distribution of pharmaceutical products. This role focuses on ensuring compliance with GMP standards, quality systems, and industry regulations. You will play a key role in maintaining and improving operational quality management systems while collaborating with various internal and external stakeholders.

Key Responsibilities:

Act as the quality point of contact for factory operations, supporting the creation and progression of quality records.
Represent Quality Operations (QO) within production operations.
Review and approve batch records, intermediate products, and associated documentation for both in-house and third-party manufacturing.
Support the approval of master batch records, SAP material data, and related processes.
Participate in internal and external audits, as well as regulatory inspections.
Investigate incidents, deviations, and customer complaints, and manage associated CAPAs (Corrective and Preventive Actions).
Provide training on quality systems and ensure effective implementation across teams.
Review and approve qualification/validation protocols and reports.
Support technology transfer projects and new product introductions.
Assist in maintaining approved supplier lists and quality agreements.
Contribute to continuous improvement initiatives to enhance efficiency and compliance.
Support GDP (Good Distribution Practice) activities, including assessing returned products and temperature excursions.
Represent QO in risk assessments and focus teams, ensuring proper documentation and approvals.
Facilitate the annual testing of product recall procedures and the generation of quality management system indicator reports.

Key Skills & Requirements:

Basic knowledge of quality systems, GMP guidelines, and pharmaceutical manufacturing processes.
Strong technical and scientific judgment with the ability to interpret complex data.
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
Effective communication and presentation skills.
Strong problem-solving and decision-making abilities.
Ability to work collaboratively within a team and manage time effectively.
Professional behavior, self-awareness, and a diplomatic approach to challenges.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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