Full Time Quality Control Analytical (Associate Manager -Manager ) Jobs, in Biocon Biologics Kebun Baharu - Ricebowl

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

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Job Responsibilities

• Ensure adherence to cGMP requirements.
• Ensure adherence to EHS compliance at QC Analytical Laboratory.
• Ensure Good Documentation Practice (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.
• Ensure the proper housekeeping and cleanliness is maintained in QC Analytical department
• 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.
• Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.
• Daily monitoring of Drug Product and Drug Substance incoming and retest raw materials, Packing Materials and Consumables in SAP system.
• Coordinate and assign activities to team members for routine test analysis and ensure task segregation is well organized to meet timelines.
• Shall co-ordination with other departments to resolve day to day activities with respect to Raw Material, Packing Materials and Water testing as per the specified standards.
• Review of Analytical reports related to Raw materials, packing Materials and Water, Finished product and stability samples.
• Approval/Rejection of Raw Materials, Packing Materials and Water
• To update Raw Materials and Packaging Material of Drug Product on monthly basis to Global QC.
• Involve in Quality Management System activity of setting and monitoring metrics of performance and KPI’s of the QMS team in QCA.
• Handling of all QMS elements (Deviation, OOS, OOT, CAPA, CC) by ensuring the raising, handling, investigations, submissions and closures and perform accordingly for QCA department.
• Perform and review investigations of Deviations, OOS & OOT raised by QCA personnel and coordinate with QA for the closure.
• Liaise and coordinate with other department e.g. Production, QA, Regulatory Sciences, etc. for issue regards to Raw Materials and Packaging Materials.
• Handling of Lab Incident investigation and ensuring proper closure of the lab incident.
• Facilitate an internal / external audit in Quality Control Analytical.
• Responsible for preparation for any revision and new of relevant document and issuance of change control form and deviation.
• Preparation and review of Study protocols
• SAP and LIMS activities as per designated roles.

Requirements

• Bachelor’s Degree and Master's Degree in Biotechnology, Biochemistry and Microbial Biotechnology or equivalent field.
• 15 - 20+ years of hands-on experience in QC Analytical department
• Experience in pharmaceutical/medical device in QCA