junior manager

2 days ago

Bengaluru, Karnataka, India Syngene International Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Date: 13 Aug 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

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