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On-site

Job Type

Full Time

Job Description

Date: 18 Aug 2025Location:Bangalore, KA, IN, 560099Custom Field 1: Manufacturing Services

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Common Responsibilities

  • Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
  • Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self & direct reports.
  • Monitor & confirm that self & direct reports adhere to the highest standards of quality, integrity & compliance for every work activity
  • Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the direct reports.
  • Attend all assigned mandatory trainings related to data integrity, health and safety measures, and monitor & confirm the same for the direct reports.
  • Participate in & support the trainings on procedures, protocols and On-the-Job activities.
  • Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
  • Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.

Safety And DI Responsibilities

  • Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the direct reports.
  • Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the direct reports.
  • Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the direct reports.
  • Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.

Specific Responsibilities

  • Perform work allocation to the direct reports and manage shift schedule.
  • Prepare and/or review procedures, protocols, and On-the-Job certification modules (training & evaluation) and verify the practices.
  • Review the shop-floor documentation and monitor & confirm that good documentation practice(s) are followed by the direct reports.
  • Maintain good housekeeping and labelling in the Clean Utility Area, laundry area and supervise the cleaning & sanitization of the area.
  • Operate the following clean utility systems through HMI/SCADA system:
    • Purified Water Generation, Storage & Distribution Systems
    • Water for Injections (WFI) Generation, Storage & Distribution Systems
    • Pure Steam Generation & Distribution System
  • Operate the Kill Plant for waste treatment as per the approved procedure.
  • Monitor the operations and perform managements of alarms during the regular operations and verify functionality of the alarms at defined frequencies as per the approved procedures and maintain the records.
  • Facilitate & monitor the daily sampling of clean utilities as per the defined water quality monitoring schedule and whenever required, share the AR number for the WFI testing with the manufacturing team.
  • Communicate any clean utility shutdown activities to the Manufacturing, QCM and EAM team, and share a formal notification to the Biocon’s B4 plant team through the form specified as per the B4 SOP.
  • Facilitate regular preventive maintenance of the clean utility systems & kill plant and periodic calibration of associated instruments as per the defined schedule.
  • Perform regular sanitization of the WFI Storage & Distribution systems and Purified Water Storage & Distribution Systems and chemical cleaning of the Purified Water Generation System at defined frequencies as per the approved procedure.
  • Facilitate and/or perform the periodic Pure Steam Quality Testing from all the user points.
  • For any breakdown of equipment in the clean utility area or kill plant area, initiate a work order through the complaint register slip to EAM.
  • Order the required logbook & maintain the necessary stocks as per the requirements and archive the documents & executed records.
  • Facilitate ordering of required chemicals for Purified Water Generation System and maintain the stocks of the same.
  • Execute the qualification protocol and study protocol related to clean utility area and kill plant area.
  • Perform & support the CAPA implementation and effectiveness checks for implemented CAPAs for clean utility area and kill plant area.
Facilitate training of contract employees on the applicable procedures.

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