Quality Control Analyst: cGMP, EHS & Lab Compliance

Biocon Biologics; Gelang Patah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company in Malaysia seeks a professional to ensure compliance with cGMP and EHS standards in their QC Analytical Laboratory. The role involves overseeing documentation practices, coordinating testing activities, and training staff. Responsibilities also include safe disposal of laboratory waste and liaising with other departments on compliance regarding raw materials. Ideal candidates will have experience in quality control practices and compliance management within a laboratory environment.

Responsibilities

• Ensure adherence to cGMP requirements.
• Ensure adherence to EHS compliance at QC Analytical Laboratory.
• Ensure Good Documentation Practise (GDP) is applied in tracking QC activities.
• Maintain proper housekeeping and cleanliness in the laboratory.
• Assist in preparation and improvement of SOPs and EOPs.
• Ensure safe disposal of laboratory waste according to regulations.
• Monitor Drug Substance and product materials in SAP system.
• Provide necessary inputs and training to analysts.
• Review and approve/reject raw materials and packaging materials.
• Investigate OOS and lab incidents, track and close CAPAs.
• Coordinate activities for routine test analysis with team members.
• Assist in internal and external audit programmes.
• Liaise with other departments on raw materials and packaging.
• Execute activities in SAP, Trackwise, LIMS as needed.
• Review logbooks periodically.

Job description

A leading biopharmaceutical company in Malaysia seeks a professional to ensure compliance with cGMP and EHS standards in their QC Analytical Laboratory. The role involves overseeing documentation practices, coordinating testing activities, and training staff. Responsibilities also include safe disposal of laboratory waste and liaising with other departments on compliance regarding raw materials. Ideal candidates will have experience in quality control practices and compliance management within a laboratory environment.