Quality Assurance Team Leader

OVERALL ROLE OBJECTIVE: To lead a multidisciplinary team of Quality Assurance personnel to assure compliance with the principles of GMP and the Pharma Services Pharmaceutical Quality System, as well as to support pharmaceutical manufacturing and packaging operations

JOB SPECIFIC RESPONSIBILITIES: The post holder will: Manufacturing, Analytical and Packaging Teams 1. Lead and develop a team of Senior Quality Assurance Specialists, Quality Assurance Specialists, Quality Assurance Coordinators, Product Review Co-Ordinators and Quality Assurance Graduates (as applicable to the individual Team Leader role) to provide high level quality governance of the Pharmaceutical Quality System. 2. Manage systems to ensure quality, regulatory and GMP compliance expectations pertaining to supply of Medicinal Products are implemented and maintained, including those where manufacture of bulk product/britestock is carried out by an external party. 3. Lead and develop a team of Senior Quality Assurance Specialists, Quality Assurance Specialists, Quality Assurance Coordinators, Product Review Coordinators and Quality Assurance Graduates (as applicable to the individual Team Leader role) to provide high level quality goverance in the manufacturing and packaging operations areas of Almac Pharma Services’ business. 4. Support the change management system in assuring that all potential patient/product impacting changes are appropriately planned, assessed and actioned in the defined timeframes and in a prospective manner (as applicable to the individual Team Leaderrole). 5. Support the deviation management system (incidents) in assuring that all deviations are appropriately reported, assessed and relevant CAPA and CAPA effectiveness reviews are completed in agreed timeframes (as applicable to the individual Team Leader role). 6. Support the Suspect Analytical Result management system (SAR) in assuring that all Sars are appropriately reported, assessed with any OOS/OOE/OOT appropriately investigated and any relevant CAPA and CAPA effectiveness reviews are completed in agreed timeframes (as applicable to the individual Team Leader role). 7. Support the review of generated Stability Documentation in assuring that all generated data is appropriately assessed and any adverse results are investigated through appropriate channels. All reviews are completed in agreed timeframes in order to meet any project milestones. (as applicable to the individual Team Leader role). 8. Oversee the Training and Development of Senior Quality Assurance Specialists, Quality Assurance Specialists, Quality Assurance Coordinators, Product Review Coordinators and Quality Assurance Graduates as applicable. 9. Ensure each new product introduction is fully assessed and managed to deliver all quality assurance requirements on time. 10. Oversee the product complaint system in assuring that complaints are appropriately assessed, responded to and actions completed in agreed timeframes (as applicable to the individual Team Leader role). 11. Deliver and manage the Product Quality/Annual Product Review (PQR/APR) process (as applicable to the individual Team Leader role).

Change Management and Material Management Team 12. Lead and develop a team of Senior Quality Assurance Specialists, Quality Assurance Specialists, Quality Assurance Coordinators, Product Review Co-Ordinators and Quality Assurance Graduates (as applicable to the individual Team Leader role) to provide high level quality governance of the Pharmaceutical Quality System 13. Oversee the change management system in assuring that all potential patient/product impacting changes are appropriately planned, assessed, and actioned in the defined timeframes and in a prospective manner. 14. Oversee the materials management system in assuring at that requirements of material control are met in order to have materials available for production operations in a timely manner. Deviation Team 15. Lead and develop a team of Senior Quality Assurance Specialists, Quality Assurance Specialists, Quality Assurance Coordinators, , Product Review Co-Ordinators and Quality Assurance Graduates (as applicable to the individual Team Leader role) to provide high level quality governance of the Pharmaceutical Quality System 16. Oversee the deviation management system (incidents) in assuring that all deviations are appropriately reported, assessed and relevant CAPA and CAPA effectiveness reviews are completed in agreed timeframes.

Lead Investigation Team 17. Lead and develop a team of Lead Investigators to provide quality investigations and implement robust CAPA action plans which to facilitate continuous improvement. 18. Become a primary point of contact for the business, providing advice/guidance on quality standards, CAPA expectation, and root cause analysis using pre-defined and proven methodologies. 19. Review the Deviation management system to ensure the timely initiation of GEMBA investigations and managing investigations / CAPA effectiveness reviews are completed within the agreed timelines. 20. Effectively communicate with Quality Assurance and other business areas to update on investigation status, restrictions on material or product, etc. Escalate to department manager and quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious. 21. Strive to ensure that preventative actions are holistic and drive continuous improvement across all sites. 22. Support investigations in other operational areas and/or other Pharma Services sites as and when required. 23. Present and defend investigations to customers and regulatory bodies.

General 24. Become a primary point of contact for the business of any areas under their remit, providing advice/guidance on quality standards, expectations, CAPA expectation, and root cause analysis using pre-defined and proven methodoligies. 25. Manage and schedule the workload to ensure client and business needs are met and ensure that adequate resources are available to support routine quality operations and business growth. 26. Communicate and engage with staff at all levels to promote the PQS and strive for an open and blame free culture. 27. Provide information to staff members at all levels thus sharing knowledge and providing visibility on the issues/resolutions and opportunities for continuous improvement. 28. Assist in monitoring and reviewing quality system elements such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-ofspecification reports, with the objective of assuring the GMP compliance and quality of pharmaceutical products. 29. Support the quality governance process by presenting metrics and trends on a monthly basis to the site quality metrics meeting and on a 6 monthly basis to the Quality Management Review 30. Periodically review quality systems and practices to identify efficiencies and to assure greater compliance. 31. Participate in the preparation, hosting and completion of responses to Customer visits/audits and Regulatory Inspections. 32. Participate in the internal audit and vendor assurance programs to facilitate the delivery of quality products / services etc from third parties. This will include audits of Drug Substance manufacturers, packaging suppliers, third party Drug Product manufacturers, service providers etc. 33. Participate in customer teleconferences / meetings / regulatory inspections to discuss any areas under their remit, should additional explanation or assurance be needed. Ensure all such customer communication, oral and written, is carried out professionally in order to develop and maintain good relationships. 34. Escalate issues through the quality management structure to ensure timely resolution. 35. Develop and manage appropriate metrics to demonstrate team performance and continuous improvement. 36. Support the wider Quality Assurance teams during periods of high demand. 37. Provide a Quality review and authorisation of a range of quality documentation including, SOPs, Policies, Guidelines, Specifications. 38. Actively integrate risk management principles into the Pharmaceutical Quality System at Almac Pharma Services. 39. Develop and manage the collection of metrics (quality indicators / KPIs) to assess the level of compliance and target areas of improvement. 40. Provide Quality Assurance support on business projects as required. 41. Keep abreast of new / revised legislation and ensure the timely assessment and communication to prepare the business. 42. Additional duties related to the assurance of GMP compliance and quality of manufactured and released pharmaceutical products are also to be performed as required.

This role may require travel and coverage beyond normal working hours as and when required. It is a condition of your employment that you are able to fulfil this element of the role QUALIFICATIONS ESSENTIAL REQUIREMENT Degree (or equivalent) in a science, life science or technical discipline or closely related field.

Note: significant relevant work experience and knowledge will be considered in lieu of degree EU only: GCSE English and Mathematics or equivalent (Grade C or above) EXPERIENCE Experience working within an established Quality System within the Pharmaceutical Industry. Experience in leading a team of quality professionals. Experience of solid oral dosage forms in development scale including clinical supply, and commercial scalemanufacture. Knowledge on Root Cause Analysis technique