Job Requirements
- Min. Bachelor's degree in Pharmacy & certified as Pharmacist is a MUST
- Min. 2 years of experience as QA Specialist or 1 year as QA Supervisor within the pharmaceutical industry
- Proven experience in deviation handling, CAPA, change management, product quality review, and audit
- Strong knowledge of CPOTB/CPOB, cleaning validation, and quality risk management
- Detail-oriented with excellent analytical thinking & problem solving skills
- Effective communication & leadership skills
- Willing to be placed in Sukabumi Factory
- Plan, prepare, and implement compliance monitoring for CPOTB and FSSC standards.
- Conduct genba, 5S, and GMP observations to ensure continuous improvement and operational discipline.
- Plan and execute internal audit programs and supplier audits to verify compliance with quality standards.
- Review batch conformity and ensure readiness for the product release process.
- Conduct Product Quality Reviews (PQR) to evaluate product performance and compliance trends.
- Coordinate with cross-functional departments regarding change control, deviations, CAPA, and complaints to ensure timely resolution.
- Develop and implement cleaning validation and product marker concepts in accordance with quality requirements.
- Plan and monitor the implementation of Quality Risk Management (QRM) activities.
- Monitor stability data and retained samples to ensure ongoing product quality.