Job Description

Support QA Operations as a valued business partner, in providing oversight to Production and QC testing activities, ensuring compliance with cGxP. Support the execution. monitoring, and continual improvement of the Company's Quality Management Systems in compliance with PIC/S GMP, cGMP and ISO: 9001:2008. Collaborate with stakeholders and provide quality oversight on the investigation of Non-Conforming/ Deviation/ OOS events, and Product Complaints. Coordinate and perform quality assessments of GMP Change Control and Corrective and Preventive Actions (CAPA) records. Participate in, or conduct Quality Risk Assessments as applicable. Support the quality review of Validation activities, including equipment, process, cleaning, and QC method validation. Support the creation of Annual Product Quality Reviews. Support the monitoring of the performance of approved Suppliers and maintenance of the quality standards of Suppliers. Assist in development of critical quality attributes, key processing/ testing parameters to ensure materials / products meet requirements. Support the provision of Quality and Technical documents for regulatory submissions. Generate quality metrics in support of management reviews, and in driving site continual improvement initiatives. Support the Batch Record review and QA Batch Release process. Participate in internal and external audit activities. Any other project / assignment that will be advised / directed by the superior.Requirement A good Degree in Chemistry/Pharmacy/Microbiology/Science. Minimum 3 years of relevant working experience in management of quality assurance and quality control, preferably in pharmaceutical manufacturing industry. Familiar with GMP and ISO systems, ICH guidelines and other regulatory guidelines. Team player with good analytical skill, good application knowledge and experience, and good communication and interpersonal skills.
Not Specified