Lowongan Kerja Depok Posisi Production Compliance Supervisor di PT Medifarma Laboratories

Description :

• Lead and/or assist with process, equipment, and facility deviations and investigations, troubleshooting and root cause analysis.
• Coordinate documentation and tasks associated with equipment and facilities: Change Management, Addition of new equipment, Calibration, and Non-Conformances and CAPAs
• Work with Production Team, Technical Operations, Maintenance, Engineering, Validation, Warehouse/Packaging, and Quality Assurance to ensure that change controls, deviations, & CAPAs are reviewed, approved, and implemented.
• Review production documentation and perform regular Quality Walk-throughs during manufacturing events.
• To establish and maintain implementation of quality management system in the Production Department.
• Ensuring that products meet all necessary standards and regulations, includes overseeing the development and implementation of quality management systems, as well as monitoring their effectiveness.
• Working closely with cross function to support consistency and updated all the time status as per Data Integrity Standard.
• Ensuring Data Integrity Assessment is up to date all the time, with support of SME of each Work-Center in Production.
• Providing report status of CAPA implementation as well as evaluation to define its improvement plan.
• Investigate quality issues and failures and apply Corrective and Preventive Actions (CAPA) to prevent recurrence and advise regarding CAPA necessary.
• Co-ordinate follow ups and responses after internal or external inspection.
• Maintenance of quality systems and cGMP compliance Understand regulatory requirements.
• Drive continuous improvement to support customer and regulatory expectations.
• Engage in discussions with customers and regulatory authorities in support of customer visits, audits, and regulatory inspections.

Requirement :

• Apothecary with minimum 3 years experience in 
• Strong experience in Compliance or Production 
• Responsible, hard worker, fast learner, and strong leadership
• Able to work individually and with team as well
• Have received training and understand the Good Manufacturing Practices (CPOB)
• Fluent in English both speaking and writing