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

Essential criteria:

• Relevant experience within a Quality Assurance Team in a pharmaceutical manufacturing or wholesaling environment.

Skills required:

• Excellent interpersonal and communication skills
• A desire and ability to maintain excellent standards within a fast-paced environment.

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