Our client is a global biopharmaceutical leader, dedicated to developing and manufacturing high-quality medicines, vaccines, diagnostics, and technologies. Their manufacturing site plays a critical role in the production of active pharmaceutical ingredients (APIs) that support healthcare products worldwide. They are now seeking a
Quality Operations Specialist
to join their on-site Quality team and support GMP manufacturing activities.
Reporting into Quality Operations, this role partners closely with Manufacturing, Engineering, Laboratories, and Supply Chain to ensure all operational activities are executed in compliance with cGMP, regulatory expectations, and site procedures. You will provide strong QA presence on the shop floor and help ensure the site remains permanently inspection-ready.
Responsibilities
* Provide QA oversight and support for GMP operations across manufacturing, laboratories, packaging, and warehousing.
* Deliver on-the-floor QA support, ensuring product quality, data integrity, and compliance during day-to-day operations.
* Review and approve batch manufacturing records, cleaning records, master records, SOPs, deviations, change controls, and CAPAs.
* Issue and review batch and cleaning documentation in line with site procedures.
* Act as a QA business partner for process validation, continued process verification, and annual product reviews.
* Support equipment qualification, engineering change control, calibration, and facility recommissioning activities.
* Provide QA support for utilities, environmental monitoring, and cleaning validation systems.
* Participate in internal audits, quality walkthroughs, and regulatory inspections.
* Promote a strong quality culture and contribute to continuous improvement initiatives.
Experience
* Degree in Pharmaceutical, Chemical, Biological Sciences, or a related discipline.
* Minimum of 5 years' experience in a GMP-regulated pharmaceutical or animal health manufacturing environment.
* Thorough understanding of batch record review.
* Strong working knowledge of cGMP and regulatory requirements.
* Experience with API manufacturing, validation activities, and quality systems is highly desirable.
* Comfortable working cross-functionally and providing real-time QA guidance on the shop floor.
* Strong communication, organisational, and stakeholder engagement skills.
* Proactive, detail-oriented, and committed to operational excellence.
Why Join
* Be part of a site with a strong focus on quality, safety, and compliance.
* Work in a highly collaborative, cross-functional manufacturing environment.
* Opportunity to make a meaningful impact on products that support animal health globally.
To learn more about this role apply online or contact Treasa Prior on for a confidential discussion.