About us:
We are PT. Amarox Pharma Global, a subsidiary of HETERO - one of world's leading producers of Active Pharmaceutical Ingredients (APIs) and generic formulations, with an active presence across 145+ countries and backed by 30 years of experience in the pharma sector
Job Descriptions:
Responsible for preparing and implementing validation activities, including master plans, cleaning and process validation, and holding time studies. This role oversees technology transfer document reviews, updates procedures, ensures compliance with company regulations and cGMP, and drives continuous quality improvement for effective and efficient operations.
Qualifications:
- Bachelor's degree in Pharmacy,
- Minimum +3 years of experience in validation activities within the pharmaceutical industry (process, cleaning, equipment, utilities, and computerized system validation).
- Understand cGMP, Quality, and regulation for pharmaceutical products
- Strong leadership and capable of working in a team
- Familiarity with risk assessment, change control, and deviation handling related to validation activities.
- Good leadership and supervisory skills with the ability to manage and develop a validation team.
- Strong analytical thinking, problem-solving, and attention to detail.
- Fluent in English
- Willing to work on shifts and to be placed in Cikarang, Jawa Barat