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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.