Executive

2 days ago

Bangalore Karnataka, India Syngene International Full time

Key Result Areas Role-specific Active involvement in all upstream manufacturing activities Perform error free operation by eliminating operational gaps in advance Active trouble shooting to minimize the various risks prior to execution and during execution Initiate and process upstream deviations investigations and closure Pre -execution activity Area and equipment readiness Issuance of raw material consumables and issuance batch records Upstream process execution Batch process operation unit operation including CIP SIP and preparation upstream accessories close monitoring of batch performance and data Follow and practice on-line documentation all the time Follow cGMP practices during the manufacturing activity and operations associated activities with QA QC and EAM Attend the training session of EHS cGMP and HRD Ensure process equipment s instruments are in Qualified in state Verify PM check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution Active coordination with inter-depts for sample submission closure of documentation and timely execution and contribution for the assigned tasks Perform on-line documentation cGMP compliance in all the manufacturing activity and timely closure of executed documents and batch records Ensure the Quality system is followed in day today upstream operations Identify the gaps in the system to improve Active involvement in all upstream manufacturing activities Perform error free operation by eliminating operational gaps in advance Active trouble shooting to minimize the various risks prior to execution and during execution Initiate and process upstream deviations investigations and closure TECHNICAL FUNCTIONAL SKILL Expertise in Upstream unit operations CHO based mammalian expression systems Strong Hands on experience with SUB Up to 2000 L scale Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area Sound knowledge and awareness of GMP controls Quality systems and regulatory aspects Experience on risk assessment tools and change management Experience on the Equipment Qualification and commission aspects

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