The Client: Located in Newry, our clients are one of the top companies who supply wholesale pharmaceutical goods.
The Role: The successful candidate will be responsible for:
- Develop and maintain all aspects of the Quality Management System (QMS)
- Deviation Management process, with investigations conducted in a timely manner, root cause identified and effective CAPAs taken.
- Complaint Management process
- Execution and closure of Recalls
- Ensure effective Training Management processes are in place across the business for GDP compliance
- Change Management process
- Qualification of outsourced activities.
- Internal Audit (Self-Inspection) program
- Responsible for the Vendor Appraisal and Approval process
- Responsible for Product / Supplier and Customer set-up and Bona-Fides
- Embed QMS Management principles in the organisation and ensure an agile quality culture.
- Ensure inspection readiness
- Report to senior management on development and improvements require within the QMS
- Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and conferences
- Assist in Regulatory product licence applications.
Hours of work
Mon - Fri
- Relevant experience within a Quality Assurance Team in a pharmaceutical manufacturing or wholesaling environment.
- Excellent interpersonal and communication skills
- A desire and ability to maintain excellent standards within a fast-paced environment.
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