Role Requirements
- Sound knowledge (10-12 years) of tablet dosage with subject matter expertise in FBP granulation (Top spray, bottom spray) & Sugar-coated tablet techniques, Hard Gelatine capsules dosage form, Injection
dosage form is a needed skill for the role.
- Excellent communication, interpersonal skills, power point presentation skills, both oral and written English. The understanding of regional language - Bahasa (Indonesia) will be an added advantage.
- Agile, shall have good managerial skills, shall be a team leader and should have problem solving ability.
- Should have a positive attitude, result oriented, competent and a good team-player with a customer Centric approach.
- Good digital/soft skills to work in the digitized space required for technical documents' generation.
- Good Project Management, Planning & Organizing skills.
- knowledge of various ICH guidelines on stability, process validation and quality & risk Management, Pharmacopoeia like IP/BP/USP, EP etc.
- Sound knowledge of technical documentation[ role pre & post Technology Transfer] is required which shall be aligned with Global quality guidelines viz, Asian, ICH, WHO. Expert in compose/review of CTD dossier quality module – Part P& Part S.