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Details

Quality Operations Team Lead


Reference:SMC8578 Location: Waterford
Qualification:DegreeExperience:Graduate
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Supervisor

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Waterford. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

- Manage/support and lead the team in ensuring smooth manufacturing operations, in handling deviations/CAPAs, change control, complaints, customer management, critical issues, recalls, etc. and that they are in full cGMP compliance to regulatory.

- Provide oversight (Review/Approval) of GMP Record/Document in ensuring compliance

- Ensuring manufacturing documentation is maintained up to date.

- Review of cGMP documents to ensure company processes comply.

- Train and assist less experienced members of the QA team on quality procedures, protocols, and documentation.

- Maintain Quality Assurance documentation.

- Support investigation of quality issues with customers and suppliers.

- Review, approve and communicate root cause and corrective action to stakeholders.

- Corrective and Preventive Actions (CPAs) - Record and monitor all problems arising, with the objective of identifying the root cause and resolution.

- Oversee the assessment and maintenance of quality related reports.

- Provide training sessions in policies, processes and procedure as required.

- Manage QA team members including assignment and supervision of work activities, setting of short-term objectives and monitoring performance.

- Maintain the quality management system and site in a state of inspection readiness for regulatory inspections.


Education & Experience


- Bachelor/Master degree in Science

- Ensure close liaison with all departments and external suppliers to resolve any queries

- Ability to oversee multiple projects simultaneously

- Experience in managing diverse relationships.


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.