To train operators on relevant SOPs and ensure adherence to the SOP
To prepare and update relevant production SOPs
To ensure adherence to the production schedule
To maintain strict cGMP adherence amongst all operators and production Personnel.
To be involved in all production new processes and all validation activities.
Ensure that all records in production are up to date
To be involved in all NC & CAPA and investigation of root cause
To be involved in internal audits
To be involved in all production improvement projects.
To ensure that all machines are operated to it’s intended use and according to SOP and maintained to their highest operation standard.
To be responsible for the Vaccine lot release activities.
To liaise with the regulatory authorities in the event of updated guidelines and regulation
To be involved in the serialization activities for vaccines.
To register a Poison A license under Solution Biologics (if required).
To maintain and update the Site Master File.
To lead and monitor all Production Personnel.
Maintain good relationships with team members, HOD, and other colleagues.
To complete other tasks assigned by the Superior.
Requirements:
A bachelor of Pharmacy from a reputable local or overseas university
Licensed Pharmacist registered with the Pharmacy Board of Malaysia
Have experience working in a pharmaceutical production environment, especially in an SVP manufacturing line (optional)
Ability to operate in a diverse team embracing multi-cultural aspects and creating an inclusive environment.
Demonstrate the ability of leadership skills including setting clear expectations, providing positive reinforcing feedback, and dealing with issues as they arise.