Junior Manager

Key Result AreasRole-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 equipments/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