Production Compliance Supervisor
- Apothecary
- Permanent
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
Job 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.
PT Medifarma Laboratories
Medifarma Laboratories is a pharmaceutical company based in Indonesia and an affiliate of United Laboratories, Inc., the biggest pharmaceutical company in the Philippines and a sister company of Darya-Varia Laboratoria, Indonesia. With its head office in Depok, on the southern outskirts of Jakarta, Indonesia’s capital, the Medifarma production facility is located in a complex that houses such big-name multinational pharmaceutical companies as Bayer Health Care, Glaxo Smith Kline, Pfizer, etc.