The primary purpose of this position is to provide leadership and direction to the Technical Services team. The role will own the responsibility for ensuring that validation and performance qualification activities and packaging material development at the site remain compliant, are reliable and effectively performed, and ultimately that the team deliver on their commitments.
As manager at PGS Jakarta, keeping your team engaged, focused and aligned on key site priorities will be fundamental to your success.
Primary duties :
- Maintain and ensure compliance in Quality and Safety such as submitting CASR, QAR, CAPA , as per committed in Technical Services team.
- Responsible for ensuring that PGS Jakarta delivers on customer expectations of supplying quality Sterile and Non- sterile products. Validation and performance qualification, packaging development schedule adherence against the Production Plan is critical.
- Manage effective validation and performance qualification, packaging development processes and ensure they are conducted in a safe and compliant work environment.
- Drive team engagement, effective communication, and the development of supervisors within the Technical Services team.
- Lead for the preparation of regulatory, customer and Pfizer global audits for the Technical Services team.
- Continuously monitor Key Performance Indicator (KPI) in Technical Services team and provide coaching and feedback as required.
- Manage and coordinate validation (manufacturing, packaging, cleaning, computerized system), performance qualification (equipment, facility, utility system) planning/scheduling and testing activities to ensure timely product supply.
- Manage and coordinate packaging material development planning/scheduling and testing activities to ensure timely product supply.
- Actively coordinate with the teams to ensure the projects (i.e., CIP, Operational Excellence, Innovation projects etc.) in Technical Services team are delivered in the most effective way.
- Minimum of 5 years+ of Experience in validation and qualification operations in Pharmaceutical Industry
- Strong understanding of cGMP and Data Integrity.
- Proven ability to engage, develop and lead colleagues in a dynamic and changing work environment.
- Clear understanding of Human Resource Management (appointment/termination of colleagues, performance management, leave management, remuneration review)
- Clear understanding of EH&S Compliance (incident management, rehabilitation, environmental controls)
- Will be adding a plus if having Certified Six Sigma Green Belt
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
Pfizer