QHS Specialist

Overview

• To release batch based on the certificate of analysis and sterilization records provided by the
• manufacturer and maintain batch records
• 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