Quality Assurance Supervisor

1 week ago

Bogor, West Java, Indonesia PT Amerta Indah Otsuka Full time 120,000,000 - 240,000,000 per year
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
Responsibilities:
  • 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.

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