1. To monitor the compliance with the requirements of Good Manufacturing Practice.2. To ensure the instructions relating to production operations are strictly followed.3. To update the real time data entry in BMR'S, ECC and other documents in DSP1.4. To execute equipment qualification protocols and validation protocols.5. To perform and document operations in accordance with cGMP.6. Maintenance of Production equipment in coordination with maintenance… Show more 1. To monitor the compliance with the requirements of Good Manufacturing Practice.2. To ensure the instructions relating to production operations are strictly followed.3. To update the real time data entry in BMR'S, ECC and other documents in DSP1.4. To execute equipment qualification protocols and validation protocols.5. To perform and document operations in accordance with cGMP.6. Maintenance of Production equipment in coordination with maintenance department.7. To comply with EHS policies and procedures8. Responsible for OTIF execution of all the activities related to Downstream Purification-1.9. To ensure the shift activities are handed over to the subsequent team appropriately.10. Data owner for process equipment used in day-to-day activity.11. To provides information guidance and recommendations to facilitate compliance with DI, GDP in documentation.12. To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).13. To prepare / review the protocols for Re-Qualification(RQ) and Periodic Qualification review (PQR).14. To execute the requalification of equipment and closure of reports15. Closure of all QMS related activities related to qualification.16. Data owner for process equipment used in day-to-day activity. Show less

Specialized in bio-pharmaceutical (production)I am a production associate at Biocon Sdn. Bhd., where my responsibilities is manufacturing of recombinant insulin and insulin analogues in downstream. I am also experience in operating downstream purification equipment which include large scale low-pressure liquid chromatography (LPLC) operations, crystallization, reaction and large scale process vessels ranging from 700L to 10kL. Have good technical knowledge and experience in… Show more Specialized in bio-pharmaceutical (production)I am a production associate at Biocon Sdn. Bhd., where my responsibilities is manufacturing of recombinant insulin and insulin analogues in downstream. I am also experience in operating downstream purification equipment which include large scale low-pressure liquid chromatography (LPLC) operations, crystallization, reaction and large scale process vessels ranging from 700L to 10kL. Have good technical knowledge and experience in using ABB system, GEA Westfalia Separator, Novasep LPLC Column. In addition, I also have experiences in preparation / review the protocols for Re-Qualification(RQ) and Periodic Qualification review (PQR), execute the re-qualification of equipment and closure of reports, Closure of all QMS related activities related to qualification. I am able to undertake large amount of routine work, cGMP, ALCOA and follow SOP/EOP. Self-motivated, hardworking, organised and able to multi-task. I strongly believe that my ability to get along with people from diverse background has helped me to grow well personally and professionally. Show less