Basic Requirements:
Education: Post-Graduate in Science / Pharmacy discipline.
Experience: Preferably 10 plus years experience in Quality Control activities and Quality Assurance in Quality Management Systems.
Special Knowledge: Good Knowledge of Analytical, Documentation / Regulatory requirements & Quality Management Systems.
Effective verbal and communication skills, collaborative team member & team leader.
Capable to work independently & efficiently.
Business understanding: Understanding the pharmaceutical industry. The key responsibilities of this role are mainly:
Specification Management
- Review, Revision, and Issuance of FPS / RMS / IMS / PMS related to LL products.
- Ensure Specifications are aligned to Pharmacopoeia requirements all the time.
- Ensure Regulatory specifications are updated & provide timely support for regulatory requests.
- Maintain Specifications throughout their life cycle.