· Comply with company policies, procedures and practices.

· Ensure compliance of team with all relevant company and customer policies, procedures and practices.

· Support in conduction of 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.

· Review facility management documents including but not limited to cleaning, maintenance, pest control and temperature monitoring.

· Responsible to maintain an effective up to date QMS documentation system.

· 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.

· Report cases on incompliance to quality and compliance manager in a timely manner and support in preparing the needed mitigation measures.

· 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.

· Support reporting manager in coordination & prompt action in case of any recall operations for medicinal products.

· Participate in monthly quality meetings with departments.

· Run ad hoc inspections & walk through to verify operation compliance at warehouse.

Value Added Service (VAS) Operations:

· Support in preparation of and training on VAS SOPs and customer specific Sops as required.

· Review of completed batch records for compliance with standard operating procedure requirements.

· Reconcile VAS material & components and determine compliance with specifications.

· Assist in investigation of non-conforming results related to either reconciliation or production activities.

· Maintenance of logs, batch records & all applicable documentation in accordance with Cgmp specifications & internal standard operating procedures.

· Maintain updated quality board at warehouse.

· Contribute to a continuous improvement agenda for quality department & support other departments in implementations of CIP & update of respective procedures.

· Attend to other duties, consistent with skills & experience, as directed by the reporting manager.

QHSE

· Conducting risk assessments & audits to identify potential hazards & risks in the workplace & recommending appropriate preventive & corrective measures.

· Monitoring & evaluating the effectiveness of HSE programs & initiatives & providing recommendations for improvement.

· Conducting regular inspections of the workplace, equipment & facilities to ensure compliance with QHSE requirements & industry best practices.

· 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 measures.

· Collaborating with other departments, contractors & relevant authorities to address HSE concerns & implement solutions.

· Keeping up to date with QHSE regulations, guidelines & industry best practices & advising management on changes & implications.

· Review DG approvals.

· 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.

· Generate reports pertaining to HSE & update QHSE board.

· Record QHSE key performance indicators on a monthly basis & issue reports as necessary.

· Suggest & advise change to ensure continuous improvement on any additional effective KPIs to be added in the system as part of continual improvement.