Paediatric Nurse
- Dublin
- Permanent
- Full-time
- The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.
- As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
- This is a 24/7 shift role required to support manufacturing operations.
- Ensure adherence to safety standards and SOPs in all activities.
- Review and approve production batch records and associated documentation for Qualified Person disposition activities.
- Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
- Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
- Offer Quality Assurance support for on-the-floor investigations and deviations.
- Review and approve deviations for closure, ensuring compliance with appropriate documentation.
- Participate in customer complaint investigations.
- Conduct routine Quality Assurance walks on the production floor.
- Review and issue logbooks, ensuring compliance with procedures.
- Provide training and guidance to staff for effective performance.
- Review and approve cGMP records, ensuring compliance with appropriate documentation.
- Support continuous improvement and Operational Excellence initiatives.
- Minimum Qualification: Science Degree /Engineering degree
- Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Strong organizational skills, including ability to follow assignments through to completion.
- Demonstrated ability in problem solving particularly in supporting non-conformance/deviation investigations.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.