QA Operations Manager
QA Operations Manager
Based in Cork Pharma Company
Excellent opportunity for a QA Operations Manager to join an expanding pharmaceutical company in Cork to join their quality team.
You will be working for an excellent employer who invests heavily in their people and it is a very exciting time to be joining the company. You will have opportunity to progress to a Senior Leadership role in time
You will be reporting to the Quality Director, you will lead, develop and co-ordinate the activities of the QA Operations Team; ensure finished products are produced in accordance with internal and external quality regulations, accept or reject batches of finished products manufactured while maintaining an effective quality system including CAPA and Change control systems. You will be involved in the quality management of the existing products but also the NPI's being introduced to the site providing Quality Support for the whole manufacturing site.
You will have the opportunity to:
- Ensure that all quality standards are adhered to for commercial product.
- Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
- Review, approve and validate protocol & reports, study protocol & reports to support Capital or key site projects as required.
- Making sure that there is stability data to support retest or expiry date, storage conditions.
- Support inspections and audits from external parties.
- Participating in internal audits as required.
- Oversee key quality systems.
- Allocating the work of the department to ensure schedule adherence in alignment with site KPIs and shipping schedules.
- Participating in the recruitment of new employees.
- Completing the Annual Appraisals of QA operations staff and ensuring stretch goals, and appropriate learning and development goals for each.
- Partaking of department budget management.
- Participate in the generation of initiatives and action plans for the development of QA operations and improvement of GMP compliance across the site.
- Participate and follow-up of audits and/or inspections carried out at the site by the authorities or clients
- Relevant 3rd level qualification.
- Minimum 4 years experience in a similar QA role within Biopharma/Pharma.
- Previous management / supervisory experience essential.
- Enrolled or have completed education to meet the requirements for position of Qualified Person (preferred but not essential)
For more information please don't hesitate to contact Aoife on 086 044 3981 to discuss the role in more.