Associate Director TPM Quality
This leading global pharmaceutical company is focused on developing, manufacturing and commercialising branded pharmaceuticals, devices and biologic products for patients around the world. Marketing a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories, this business has grown to be one of the global leaders in the pharmaceutical industry. Employing over 30,00 staff globally with revenues exceeding 15B per annum, this innovator not only services over 100 countries globally but has one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
- Providing QA oversight of GMP systems operating at CMO’s and internal/external supply chain operations
- Provide guidance and support to clients in defining QA needs for new and existing systems based on regulatory agency requirements and business objectives.
- Support the maintenance and development of Global TrackWise workflows used for Change Control, Deviation Management and CAPA.
- Support the generation and routine update of quality agreements with affiliate organisations and MAH to support existing licenses and authorisations.
- Participation in preparatory activities for site regulatory, customer and corporate inspections (HPRA, FDA, TUV)
- Provide QA and Compliance support to internal and external stakeholders in relation to quality management systems and processes.
- Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
- Develop, track and maintain training records for all TPQC QA personnel & site wide cGMP training records, assessment scores and course evaluation forms for each department.
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
- Perform assigned task in accordance with procedural requirements and scheduled timelines. Notify the Associate Director and other impacted stakeholders if procedural requirements or timelines are not being met.
- Bachelor’s Degree required. Chemistry or Life Science degree preferred.
- Minimum of 7+ years’ experience in QA/Compliance in pharmaceuticals or related industry.
- Detailed knowledge of cGMP requirements and industry best /current regulatory expectations.
- Strong analytical skills and knowledge of quality systems.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin North