Lowongan Product Release Senior Officer di PT Bayer Indonesia

YOUR TASKS AND RESPONSIBILITIES

• Perform review Batch Record, Lab Work Sheet and e-Batch Report Review in MES Pass-x System for releasing process.
• Perform MBR review in Pas-x for dispensing process
• Support disposition batches of packing materials, raw materials, imported bulks or products (both physically/its hard copy and the SAP system)
• Do deduction sample for Packaging material after releasing process.
• Handling of retained sample checking.
• Lead coordination to ensure quality management system in product release area are managed properly (SOP update, training, CAPA, CMS etc).
• Perform execution on quality management system task in product release area.
• All activities related job functions must be considering the OE culture and reducing complexity in QA Compliance area.
• Follow up CAPA as assigned capa owner in Dev@com system, action task from the change management system to ensure the CAPA and task are closed timely manner.
• Support continuous improvement of quality aspect in batch disposition relevant area and implementation of the agreed improvement in batch disposition areas.
• 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.
• Support for OHSERA (Occupational Health Safety and Environment Hazard Identification Risk Assessment) in working area and complete training for implementation of OHSERA.

WHO YOU ARE

• Pharmacist
• Having exposure to QA/GMP compliance or manufacturing at a pharmaceutical manufacturer.
• 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.
• Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
• Skilled to work within an international team and ability to work within teams.
• Having high motivation to learn new things.
• Having good writing and communication skill both in English and Bahasa.