Job Scope:
1. Maintain site-wide compliance by ensuring all activities and documentation are current, effective and in-use.
2. Ensure all Internal and External Audit including Third Party Audit Preparations are complete.
3. Assist in supplier accreditation/qualification and ensure compliance to required
documentation
4. Support in ensuring management of all Quality Management System-related
documents.
Duties & Responsibilities:
1.) Responsible in monitoring and maintaining completeness of documentation in all GMP processes in the company.
2.) Ensures all documentation for supplier accreditation/qualification are complete and current in compliance to regulations and customer requirements.
3.) Ensure annual training requirement for the company is complied with.
4.) Support safekeeping of all documents registered under Document Control Center.
5.) Facilitate Internal Quality Audit Team and its functional activities
6.) Facilitate all external audits (Regulatory and Certifying bodies, Clients/Customers)
6.) Support in executing continuous improvement actions and projects
7.) Ensure compliance to cGMP/GDP, FDA, Halal, FSSC, customer and other regulatory and statutory requirements.
8.) Provide assistance in deviation investigation, robust CAPA identification and implementation.
