Quality Control Analytical

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

Job responsibilities

1. Ensure adherence to cGMP requirements.
2. Ensure adherence to EHS compliance at QC Analytical Laboratory.
3. Ensure Good Documentation Practise (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.
4. Ensure the proper housekeeping and cleanliness is maintained in the laboratory.
5. Assist in preparation and continuous improvement of all relevant SOPs, EOPs, Specifications and ensure those procedures are revised and updated in accordance to stipulated interval and as per cGMP requirement / latest pharmacopoeia.
6. Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.
7. Daily monitoring of Drug Substance, Drug product incoming and retest materials in SAP system. Also, planning and monitoring of the In-Process, Finished product and stability testing samples.
8. To provide necessary inputs to analysts and required training to analysts.
9. To review the ATR’s and approve/reject Raw Materials, Packaging Materials, Consumables and Water.
10. To investigate OOS and lab incidents in timely manner and to track and close CAPA’s resulting from investigations.
11. Coordinate and assign activities to team members for routine test analysis and ensure task segregation is well organized to meet timelines.
12. Facilitate, review and assist in internal audit and external audit programme.
13. Liaise and coordinate with other department e.g. Production, QA, Regulatory Sciences, etc. for issue regards to Raw Materials and Packaging Materials.
14. SAP, Track wise, LIMS activities as per the designated roles.
15. Review of logbooks on periodic basis