Senior executive

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