Barden are delighted to be partnering with our Pharmaceutical client in their search for a Process Expert.
This position will provide frontline support to manufacturing operations, working closely with shift teams to ensure each batch is produced safely, on time, and in full compliance with batch instructions and quality standards.
ABOUT THE ROLE:
* Act as Subject Matter Expert (SME) for product and process knowledge, monitoring performance trends and contributing to the Annual Product Quality Review (APQR) and process innovations.
* Evaluate and troubleshoot product and process-related issues, including deviations, complaints, out-of-spec (OOS), and out-of-expectation (OOE) events.
* Ensure all critical process parameters are followed and remain within the limits outlined in approved documentation.
* Support the management of process changes using appropriate change control procedures.
* Create and maintain master manufacturing documentation such as Master Batch Records, Bills of Materials (BOM), recipes, Quality Risk Assessments, and Zurich Hazard Analyses.
* Oversee the creation and upkeep of production SOPs and Master Batch Records, ensuring consistency and compliance across operations.
* Collect data for ongoing process verification (OPV) and assist the Product Steward in monitoring product performance and implementing corrective/preventive actions (CAPAs).
* Support process validation activities, including the review of validation protocols and reports for technical accuracy and assisting in the execution of validation and improvement projects on the shop floor.
* Contribute to root-cause investigations, Quality Risk Assessments, and development of process control strategies alongside the Product Steward.
* Maintain inspection readiness by ensuring all processes are in line with regulatory expectations and internal standards.
* Support process optimisation and new technology introductions aimed at enhancing productivity and operational efficiency.
ABOUT THE PERSON:
* BSc within a scientific discipline (Pharmaceutical Sciences / Engineering)
* 3+ years of hands-on experience in a GMP regulated manufacturing environment, preferably in a process support capacity.
* Strong knowledge of pharmaceutical processes, with a solid understanding of GMP compliance and regulatory requirements
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