Hybrid Quality Assurance Specialist: GMP & Audits

MSD; Ballydine; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Hybrid work

Job summary

MSD in Ballydine, Ireland, is seeking a Quality Specialist to support day-to-day QA activities on site as a core member of the Process IPT. You will review batch, cleaning and testing documentation and ensure OOSs and deviations are documented with CAPAs.

The role involves deviation investigations, quality systems guidance, risk assessments, change controls, and annual reviews, with hybrid work and an equal opportunity ethos.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems such as SAP and Trackwise.
• Spray drying experience desirable.
• Knowledge and expertise in Lean / Continuous Improvement.
• GMP requirements for electronic/paper-free operations.
• Experience in High potency manufacturing desirable.
• Excellent written and oral communication; able to share and receive information.
• Teamwork, adaptable, and able to maintain high standards.

Responsibilities

• Participate as functional expert in the cross functional team that manages production right first time at site.
• Review and approve batch, cleaning and testing documentation.
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring; perform trending on deviations to identify improvements.
• Provide knowledge of quality systems and ensure root cause is identified with corrective actions completed.
• Provide guidance on quality requirements to maintain validation status, including participation in risk assessments.
• Provide feedback on recurring issues to ensure continuous improvement.
• Ensure change controls are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Lead audits to support GMP walkdowns and scheduled audits.
• Generate and communicate quality metrics.
• Create, review and approve quality procedures.

Skills

Quality IT systems

Lean CI

GMP knowledge

High potency

Communication skills

Teamwork

Decision making

Adaptability

Education

Degree in Science or Pharmacy

Tools

SAP

Trackwise

Job description

MSD in Ballydine, Ireland, is seeking a Quality Specialist to support day-to-day QA activities on site as a core member of the Process IPT. You will review batch, cleaning and testing documentation and ensure OOSs and deviations are documented with CAPAs.

The role involves deviation investigations, quality systems guidance, risk assessments, change controls, and annual reviews, with hybrid work and an equal opportunity ethos.