Job Summary:
This role allows you to enhance our QMS, ensuring compliance and maintaining meticulous documentation and traceability.
Job Descriptions:
· Maintain and improve the Quality Management System.
· Serve as the document controller for the Quality Manual, Standard Operating Procedures, Specifications, Work Instructions, Forms, Charts, Records and Quality Reports.
· Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and other regulatory requirements.
· Prepare the annual Product Quality Review Report and Management Review Report.
· Follow through on change controls.
· Conduct process deviation investigations and follow up on CAPA implementation for closure.
· Handle quality issues in manufacturing operations.
· Handle customer complaints, product recalls, returns, and counterfeits.
· Control and check artwork and drawings for packaging materials.
· Ensure machine testing, trial runs, qualifications, and validation meet compliance standards.
· Monitor the accelerated and real time stability program.
· Ensure that Good Documentation Practices and traceability are in place.
· Undertake any additional tasks as assigned from time to time.
Job Requirements:
· Degree in Pharmaceutical, Chemical, or a related field.
· At least 3 years of experience in conducting quality assurance activities.
· Strong understanding of quality management systems, including ISO 9001, cGMP
· Good follow-up skills with excellent interpersonal abilities.
· Meticulous and well-organised.
· Proficient in Microsoft Office.
