Production Compliance Staff

Qualifications:- Bachelor degree in Pharmacy, preferable Apothecary- Having experience minimal 1 year in Production or Quality Assurance at Pharmaceutical company- Having knowledge about cGMP- Active English both written and spoken is an advantage- Willing to be placed in CikarangJob Summary:- Responsible for ensuring all production processes and activities are conducted in accordance with Current Good Manufacturing Practice (cGMP) guidelines, and actively managing the quality system within the production area.- Coordinating investigation, root cause analysis, and report generation for any deviations (non-conformances) occurring during the production process. Ensuring Corrective and Preventive Actions (CAPA) are implemented and verified effectively.- Monitoring the progress and effectiveness of all CAPA plans resulting from deviations, audits, or change control to ensure timely closure and sustained compliance.- Managing the change control system in the production area, from submission, risk assessment, controlled implementation, to change closure, to ensure that any modification to processes or equipment does not compromise product quality. - Preparing and updating Standard Operating Procedures (SOP), Machine Operating Procedures (MOP), Machine Sanitation Procedures (MSP) and Batch records to align with current cGMP regulations and validated production processes.- Developing and implementing Quality Risk Management (QRM) activities within the Production department to proactively identify, assess, and mitigate potential quality risks in processes and operations.- Implementing Good Documentation Practice (GDP) throughout the production department.- Ensuring that the production training program is carried out according to schedule to maintain personnel competency and compliance with quality standards.- Assisting production activities and participating in the preparation of monthly production reports.