Compile all required documents based on requirement of manufacturer/supplier certification by coordination with supplier/manufacturer.
Lead the coordination with QC in term of certification process as per update regulations.
Support to provide additional documentation as per requirements of Regulatory, Development or Affiliates.
Maintain the Supplier and Manufacturer Management database to ensure that all manufacturer and supplier already align with the current status..
Manage complaint and rejection management and tracking to ensure that CAPA required is implemented and follow up for effectiveness in the future. Database of complaint and rejection also required to be maintained.
Responsible to maintain the supplier management process including supplier evaluation, supplier audit schedule with proper follow up and controlling process.
Involve and support for the requirements of change control process which related to supplier /manufacturer change of raw materials or packaging materials.
Support QSS Supervisor in reporting progress report of Quality Management review in quarterly basis.
Manage GMP training for Cimanggis Site and maintain its database. Provide GMP training yearly plan, and afterwards track and support completion of plans. Provide GMP training module as well as being GMP trainer.
Coordinate virtual class training as per scheduled by Global as needed.
Upgrade his/her-self in management and professional skills on GMP aspects.
Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department.
All activities related job functions must be considering the OE culture and reducing complexity in QA Operations area.
Be a Pharmacist (Candidate must possess at least a Bachelor's Degree, Pharmacy/Pharmacology or equivalent)
Having exposure to QA/GMP compliance or manufacturing at a pharmaceutical manufacturer.
At least 2 year(s) of working experience in the related field is required for this position.
Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes). Be familiar with BHC GMP Policies and Directives through training to enable controlling implementation into local practices.
Skilled to work within an international team and has ability to work within team.
Well-developed interpersonal, intercultural, communication and networking skills for external and internal working contacts.
Be able to resist any influence, which would hamper management decision making
Preferably Staff (non-management & non-supervisor)s specializing in Healthcare - Pharmacy or equivalent.
Full-Time position(s) available.
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power.
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