Quality Manager

Job Description

I am working with my client, a well-known pharmaceutical company, who are seeking a Quality Manager to join their growing team.

This person will be responsible for driving a compliant work environment, maintaining the sites quality management system, enhancing customer relationships, and providing leadership for the site regarding customer and product requirements. This is a full-time permanent role based on site near Waterford.

This person will have experience working in a similar role coming from a Pharmaceutical or highly regulated industry. Experience in GMP and working towards relevant working standards including ISO 9001 and ISO 15378. Previous people management experience essential as this role will have direct reports at management level and numerous indirect reports. A level 8 degree in science or relevant discipline also essential. Excellent communication skills and front facing customer experience essential for the role with the ability to different challenges as they arise.

Responsibilities:

• Lead a high performing team to deliver business goals, objective and KPIs.
• Drive quality improvement projects to minimise CAPAs and investigate RCA.
• Host Quality Management reviews in adherence with timely action, follow up and close.
• Approval of change controls, qualification of new equipment and validation of new processes.
• Engage with customers to ensure concerns/complaints are communicated effectively and CAPAs are implemented in a timely manner.
• Assist and support with customer expectations and problem-solving efforts.
• Responsible for quality data trending for CAPAs, OOS, deviations, customer complaints and change requests and driving quality improvement on site.
• Defines audit plans for QA process and internal audit for the site liaising with auditors on schedules.
• Ensure site inspection readiness for third party audits.
• Gather data and reporting on annual product reviews.
• Support data gathering for regulatory submission to authorities as required.
• Final batch release decision including execution and final disposition of IPC and incoming testing and trending this data.
• GMP and QMS processes training as required.

If this role is of interest, please 'apply now' or contact me on aodriscoll@morganmckinley.com or on 021 2300 300.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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