About the Job

• To release batch based on the Certificate of Analysis and sterilization records provided by the manufacturer   and maintain batch records as per cGMP
• Actively involved in Value added service Operations.
• Support in conducting training and implementation of QMS, SOPs and customer specific SOPS according to international and local good manufacturing and distribution practice as well as customer requirements.
• Perform internal inspection as delegated by quality and compliance manager as per the annual inspection schedule, prepare inspection report and follow up on observation closure.
• Participate in complaint review on case-by-case basis, providing support to customer service & warehouse team in compliant form filling & investigation; performing root cause analysis, supporting in corrective action & preventive action (CAPA) report preparation & following up until case closure.
• Maintenance of logs, batch records & all applicable documentation in accordance with Cgmp specifications & internal standard operating procedures.
• Conducting risk assessments & audits to identify potential hazards & risks in the workplace & recommending appropriate preventive & corrective measures.
• Providing training & awareness programs to employees & contractors on HSE policies, procedures & safe work practices.
• Investigating incidents, accidents & near misses & providing reports and recommendations for preventive measure.
• Participating in emergency response drills & exercises & providing support during actual emergencies or incidents.
• Maintaining accurate records & documentation related to HSE activities, including incident reports, inspection reports & training records.
• Contribute to a continuous improvement agenda for quality department & support other departments in implementations of CIP & update of respective procedures.