Specialist

Syngene International; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Syngene International in Bengaluru is seeking a professional for upstream manufacturing activities. The role focuses on trouble shooting, deviations initiation and closure, material/tool readiness, batch record issuance, and strict on-line documentation adherence.

The position emphasizes cGMP practices, QA/QC collaboration, and training participation in EHS and HRD programs, to ensure compliant batch execution in a controlled environment.

Responsibilities

• 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.
• Follow and practice on-line documentation all the time.
• Attend the training session of EHS, cGMP and HRD.

Job description

• 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.