MAIN FUNCTIONS:
- Form A license holder and other license as required by regulatory.
- Liaise with regulatory body regarding pharmaceutical compliance affair.
- To update local and overseas countries on regulatory requirement for implementation.
- Involved in day-to-day pharmaceutical manufacturing operations and ensure compliance to PIC/S GMP standard.
RESPONSIBILITIES:
- To assist in maintenance of product license with local and overseas authority.
- To prepare product registration dossier for local and overseas market.
- To assist in regulatory audits and response to the authority query.
- To assist post-marketing product query or correspondence and work closely with QA/QC department pertaining to product quality issue.
- Responsible for all dispensing materials and activities to use in production.
- Maintenance of controlled drugs and records, including the storage and sale.
- Review and update SOP relating to the production periodically.
- Together with Production Manager, handling and managing of production issue raised by the production team.
- Work together with QA to arrange training to production staff on SOP and cGMP.
- Work closely with QA/QC department to maintain cGMP standard.
- Support Beacons E-Commence project.
- Be involved in other company projects.
REQUIREMENTS:
- Candidate must possess at least Bachelor's Degree of Science (Pharmacy).
- At least 3 Year(s) of working experience in the related field is required for this position.
Other Informations:
- 5 days week
- Permanent position with 2 years lock-in period.
