Deskripsi Pekerjaan
Medion Farma Jaya is a distinguished multinational player established in 1976, operating at the forefront of the pharmaceutical and livestock industries. We are committed to excellence and innovation, and we are currently seeking a detail-oriented Quality System / Assurance professional to join our dynamic team in Bandung.
As a Quality Assurance specialist, you will play a pivotal role in ensuring our products meet the highest international standards of safety, efficacy, and quality. You will be responsible for maintaining the integrity of our quality management systems (QMS) and ensuring full compliance with Good Manufacturing Practices (GMP) and relevant regulatory requirements. If you are passionate about quality and have a strong background in system assurance, we want to hear from you.
Tanggung Jawab
- Conduct regular internal quality audits and inspections to ensure adherence to Good Manufacturing Practices (GMP) and ISO standards.
- Manage and maintain the Quality Management System (QMS) documentation, ensuring all records are accurate, up-to-date, and compliant.
- Investigate and resolve quality complaints, non-conformities, and deviations in production processes.
- Coordinate with cross-functional teams to implement corrective and preventive actions (CAPA) effectively.
- Monitor regulatory changes and ensure company processes remain compliant with local and international pharmaceutical regulations.
- Train production and operational staff on quality standards, procedures, and compliance requirements.
- Oversee supplier quality agreements and conduct vendor audits for raw materials.
Kualifikasi
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
- Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical or food manufacturing industry.
- Strong knowledge of GMP, ISO 9001, or other relevant quality standards.
- Excellent understanding of regulatory affairs and documentation standards.
- Strong analytical skills with the ability to identify root causes of quality issues.
- Proficient in using quality management software and Microsoft Office Suite.
- Ability to work independently and manage multiple priorities in a fast-paced environment.