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Barden are delighted to be supporting our rapidly growing Global Pharmaceutical and Healthcare client in their search for a Supplier Quality Specialist. The Supplier Quality Specialist will participate as a team member managing data which facilitates monitoring supplier activity to ensure compliance, manage risk and minimise supply interruptions.
ABOUT THE ROLE:
- Execution of Quality Management System activities as it applies to Supplier Quality functions.
- Generation of departmental metrics and KPIs
- Surveillance of regulatory authority actions impacting business operation
- Generation and distribution of supplier scorecards
- Tracking and maintenance of quality agreements
- Provision of GMP documentation in adherence to quality agreements
- Documentation control arising from Quality Systems action items.
- Preparation of annual site risk assessments
- Support the preparation and periodic review of Supplier Quality SOPs.
- Partner with Supplier Quality Auditors to enhance departmental audit processes.
ABOUT THE PERSON:
- 2+ years pharmaceutical manufacturing experience in a regulated facility
- Broad knowledge of at least one manufacturing dosage form
- Knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment
- Knowledge of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
Please get in touch with Aidan Crowley in Barden (aidan.crowley@barden.ie) to discuss further.
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