QA Specialist (MES)

CareerWise Recruitment; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

CareerWise Recruitment seeks a QA Specialist (MES) for our Limerick-based pharma client. You will lead QA governance for MES systems, investigate issues, and ensure GMP compliance across documents and change controls.

You will support audits, participate in quality meetings, and drive the site quality program. A strong MES background and GMP knowledge are essential for success in this role.

Qualifications

• 5 years experience in a MES/QMS role.
• BSc/MSc/PhD in Chemistry, Engineering, or related discipline.
• Solid understanding of GMP requirements and regulatory guidelines.
• Experience with quality systems, change controls, deviations, and investigations.

Responsibilities

• Provide QA leadership, direction, and governance for MES and MES-related systems.
• Investigate and troubleshoot MES-related issues.
• Manage quality matters specific to the area of responsibility.
• Approve quality-related documents and ensure GMP requirements are met.
• Promote safe practices and escalate safety concerns.
• Support audits from an MES perspective and assist cross-functional teams.

Skills

Quality leadership

GMP knowledge

QA systems

Audit support

Education

BSc/MSc/PhD in Chemistry or Engineering

Job description

QA Specialist (MES) is required by CareerWise Recruitment for our Limerick based Pharma client.

Responsibilities:

• Provide Quality leadership, direction, and governance for MES and MES related systems.
• Investigate and troubleshoot issues relating to MES and MES related systems.
• Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility.
• Approve appropriate quality-related documents. An approval signature confirms that GMP requirements have been met.
• Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices and promptly report any safety concerns.
• Promote and encourage Quality culture and promptly report any compliance concerns.
• 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.
• Provide backup cover in the case of absence for any identified roles.
• 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.
• Support cross functional teams in audit preparation activities.
• Carry out audit trails reviews as per site procedures.
• Liaise with Global Quality Standard owner when deemed necessary.
• Review and approval of change controls, deviations, failure investigations, if applicable.
• Report and elevate 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.

Requirements:

• May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline.
• 5 years experience in previous MES role

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