QA Specialist (MES)
The successful QA will provide quality leadership, direction, and governance for MES and MES related systems. Investigate and troubleshoot issues relating to MES and MES related systems.
The QA Specialist will manage quality-related matters specific to area (Quality System or Quality Program) of responsibility. Approve appropriate quality-related documents and qualified BSc, MSc or PhD in Chemistry, Engineering, or related discipline.
Responsibilities:
- Provide Quality direction and oversight for MES systems.
- Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.
- Contribution to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.
- Assure consistent implementation of standards across the Quality System.
- Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.
- Interpretation and application of emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.
- Support audit logistics from an MES perspective.
- Carry out audit trails reviews as per site procedures.
- Liaise with Global Quality Standard owner when deemed necessary.
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
- Assess the Quality Impact of quality events associated with the area(s) of responsibility.
- Review and approval of change controls, deviations, failure investigations, if applicable.
- Report and escalate critical quality issues to appropriate level of quality management for resolution.
- Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
- Participation in the site self-inspection program of the area(s) of responsibility for compliance with the GQS & local procedures.
- Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility.
Job Type: Fixed term
Contract length: 12 months
Pay: From €50.00 per hour
Work Location: In person
