Quality Assurance, Team Leader
Our client is a highly successful fast growing multinational biopharmaceutical manufacturer. The newly appointed Q.A. Team Leader reports to the Quality Assurance Manager
And interfaces with internal departments, other company manufacturing sites, contract manufacturers, suppliers, corporate Quality and the site management team.
Purpose of Role
- § The Quality Assurance Team Leader has a primary role in (1) assuring that products are manufactured and released in accordance with relevant cGMPs and (2) leading the QA team to achieve the above in an inclusive, positive team based environment.
Key Accountabilities :
- Provide quality expertise & support to the QA team and site.
- Implement and maintain compliant quality assurance systems on-site.
- Leads team of Quality Assurance specialists to excellent performance through a structured quality system delivering compliance, customer service and a positive team based work environment.
- Oversees the day to day management of QA systems, directing the workload of the QA Specialists.
- Provide clear open communication with the QA team and site.
- Effective interaction with other departments on matters related to quality.
- Ensure compliance to the Quality Management System is maintained and its effectiveness monitored (ref. EC Guide to GMP for medicinal products)
Key Performance Indicators
- QI & RFT score vs. site targets
- Completion of reviews within agreed site timelines.
- Complaint Closure vs. Due Date
- Positive, inclusive team culture.
- Completion of PSRs and CSCRs/CSRRs in a timely manner
- Safety performance in accordance with the requirements of the 5* programme and site goals.
- Delivery of projects versus plan.
Qualifications
- Diploma/ Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)
Skills & Knowledge
- Operational experience of quality systems in a dynamic manufacturing environment.
- Detailed knowledge of quality systems.
- Effective technical knowledge of on-site manufacturing processes.
- Knowledge of requirements for cGMP, US and EU regulatory requirements.
- Full understanding of relevant quality and compliance regulations
- Able to manage projects to plan/budget.
- Effective facilitator.
- Good communication skills at organisation, team and individual levels.
- Understands KPI's for the team and site.
Experience
- 3 - 5 years experience working in a Healthcare manufacturing environment - ideally most of which would be in the pharmaceutical sector.
- Experience of managing teams would be an advantage.
Personal Characteristics
- Natural influencer and works well as part of a multi-functional team.
- Adaptable and flexible as well as a pragmatically minded problem solver.
- Energetic in the pursuit of improved processes and ultimately improved performance.
- Strong patient focus
CV to Gerry Kennedy Recruitment for Technology 01 2302400 gerry@rftgroup.ie |
