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Quality Operations Leader

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 18182

Quality Operations Leader-Pharma-Waterford

The Quality Operations Leader must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements. You will effectively manage and report all Quality Metrics within the Microbiology team including Exceptions, CAPA’s, Change controls, and SOP’s.

Overview of Main Responsibilities (full job description available on request):

  • Lead cross-functional risk assessment as required within the team.
  • Assist in problem-solving within the department.
  • To ensure processes and systems are in place to ensure that Quality/CAPA-related project work is completed as required and associated customer reports are available in a timely manner.
  • Responsibility for managing the completion of compendia updates assessments for microbiology.
  • To provide continuous feedback to all members of the team on all items in relation to customer or Quality requirements/changes.
  • To handle all customer-related queries and lead the investigation of any complaint, liaising with their team to problem solve these queries if needed.
  • To lead internal and External/regulatory audits for the area of responsibility, including audit preparation, area tour, support queries during the audit, and follow-up of actions to closure. Finalising CAPA’s and associated deadlines.
  • To approve and keep updated laboratory SOPs in their area of work.
  • To identify any opportunities for improvement of quality and customer service and lead the team to implement continuous improvement initiatives/projects.
  • To establish and manage key metrics in the areas of quality, customer satisfaction/delivery. Ensuring specific targets are set, met and any trends noticed are addressed.
  • To ensure all related documentation is completed and filed accurately, updated as required, and on time in line with company procedures.

What the ideal candidate looks like:

  • A Degree in a relevant discipline.
  • Preferably 3 – 5 years experience in a GMP environment.

What you will get in return:

  • Competitive Salary (depending on experience).
  • Bonus.

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675