Quality Assurance Officer (1 Year Contract)

Job Descriptions:

• Maintain and improve 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.
• Assist in preparing the annual Product Quality Review Report and Management Review Report. 
• Assist in following up the change controls.
• Assist in the process deviation investigations and follow up on CAPA implementation for closure.
• Assist in handling quality issues in manufacturing operations.
• Assist in handling customer complaints, product recalls, returns, and counterfeits.
• Assist in checking artwork and drawings for packaging materials.
• Ensure machine testing, trial runs, qualifications, and validation meet compliance standards.
• Assist in monitoring 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:

• Diploma in Pharmaceutical, Chemical, or a related field.
• At least 2 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.