ey Responsibilities:
- Apply the latest GMP/CPOB standards in all quality-related activities.
- Conduct in-depth Quality Risk Assessments.
- Perform Gap Analyses and implement CAPA (Corrective and Preventive Actions).
- Prepare and compile Product Quality Review (PQR) reports.
- Implement and maintain the Quality Management System (QMS).
- Oversee and coordinate Change Management processes.
- Conduct thorough inspections of production processes and equipment to identify and resolve quality issues.
- Collaborate with production teams to investigate and address quality-related concerns.
- Assist in developing and implementing quality control procedures and protocols.
- Support continuous improvement initiatives in the company’s quality management system.
What We’re Looking For:
- Bachelor’s degree in Pharmacy (Apoteker) with a valid license (STRA).
- At least 1 year of experience in a Quality Assurance role, preferably within the pharmaceutical industry.
- Solid understanding of quality control principles, methods, and regulatory standards.
- Strong analytical and problem-solving abilities.
- High attention to detail and accuracy in documentation and reporting.
- Proficient in English (both written and spoken).
- Skilled in Microsoft Office applications.
- Able to work collaboratively across departments.
- Honest, reliable, and able to perform under pressure.
- Adaptive and open to change in a dynamic work environment.
Job Types: Full-time, Contract
Application Question(s):
- Ceritakan pengalaman Anda saat menemukan penyimpangan (deviation) yang cukup krusial dalam proses produksi farmasi. Apa yang Anda lakukan untuk menangani situasi tersebut dan bagaimana hasil akhirnya?
Education:
- S1 (Preferred)
Experience:
- Quality Assurance at pharmaceutical industry.: 1 year (Preferred)
Language:
- English (Preferred)