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Executive
2 weeks ago
Date: 15 Jul 2025
Location:
Bangalore, KA, IN, 560099
Custom Field 1: Manufacturing Services
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
