Product Quality Assurance Senior Officer

YOUR TASKS AND RESPONSIBILITIES

• Perform MBR review in Pas-x for dispensing process, perform review Batch Record, Lab Work Sheet and Batch Report Review in MES Pass-x System for releasing process, and perform archiving batch record.
• Support disposition batches of packing materials, raw materials, imported bulks or products (both physically/its hard copy and the SAP system).
• Perform PQR report on every reporting year (January of following year) by reviewing batch records, reviewing the results of assay testing and critical-in process control parameter, reviewing the process capability index of each result, reviewing complaints, deviations, OOS, Non-conformity, Stability study, changes, process validations report following valid SOP that notified in PQR period review.
• Perform review activities and progress report environmental monitoring and review GMP alarm report.
• Perform Local Risk Assessment Management following Valid SOP.
• Perform QA review for Bill of Material initiation or revision and review Specifications.
• Perform execution on quality management system task or CAPA in product quality assurance area, ensure the CAPA and task are closed timely manner. 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.
• Perform monitoring and follow up Corrective Action/Preventive Action (CAPA) including its verification from PQR and RA in dev@com system.
• Perform and implement quality management system in Product Quality Assurance area implemented properly (SOP update, training, CAPA, CMS etc).
• Perform sample deduction for packaging material after releasing process.
• All activities related job functions must be considering the OE culture and reducing complexity in QA Compliance area.
• Support quality monthly report and KPI related PQA area and continuous improvement of quality aspect and implementation in PQA area.
• Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within PQA area and 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
• 2-3 years’ experience in QA/GMP compliance aspects 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.
• Deep knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
• Knowledge of occupational safety, health, and environmental requirements.
• Skilled to work and ability to work within teams.
• Having high motivation to learn new things.
• Having good writing and communication skill both in English and Bahasa.