As the PET QA Facilitator, you will be responsible for ensuring the quality of licensed and clinical products manufactured at Maihara site.
The details are;
- Responsible for ensuring the quality of licensed products manufactured at Maihara site.
- Approves Deviations, Customer complaints, CAPAs, and GMP records.
- Interprets and implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections.
- Communicates company goals, safety practices, and deadlines to team. Motivates team members, provides guidance and leadership, assesses performance and help with development of direct reports.
- Responsible for hiring and training, and to keep management updated on team performance.
- Communicates concerns and policies among management and team members.
- Ability to provide constructive feedback to staff.
- Responsible for staff supervision and development including scheduling, recruiting and performance management.
- Ability to develop staff through feedback and coaching and set mid and short-term priorities.
- Builds and motivates teams.
Minimum Requirements :
- BS or MS degree
- 10+ years in a biotech/pharmaceutical industry with Bachelors
- 5+ years of experience in biotech/pharmaceutical Quality
- Advanced knowledge of GMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
- Demonstrated management skills; ability to influence and engage direct and indirect reports and peers.
- Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.