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Designation: Asst Manager EHS

Location: Hyderabad, Telangana

Job Description:

Health, Safety and Environment

  • Reporting for any unsafe conditions and incidents to HOD & HSE.
  • To ensure adherence to safety procedures and Instructions.
  • To ensure incident reporting, lead investigations, and CAPA implementations.

Sterility Assurance

  • Provide guidance and support to customers related to bulk manufacturing suites in sterility assurance programs.
  • Review of facility layouts and involve in the technical discussions pertaining to the same.
  • Review sterilization validation (Moist/Dry heat) and facility qualification protocols.
  • Review water system and performance qualification protocols and reports.
  • Review sterilizing grade filter validation protocols and reports.
  • Review cleanroom entry/exit practices in compliance with environmental zoning.
  • Maintain database for sterility assurance activities and tracking the progress.
  • Analyze environmental monitoring and clean utility monitoring trends periodically.
  • To participate and assist where required in internal/external audits of sterile processes.
  • Investigate deviations/excursions and review deviation/excursion reports.
  • Perform gap analysis for the practices employed in the site against the global standards.
  • Maintain inspection readiness activities during inspections.
  • Responsible for identification, analysis, evaluation & documenting the risk and ensuring the implementation of the appropriate mitigation plans.
  • Responsible for approving risk assessment, Performing risk review, and documenting the same.

Quality Management System

  • Evaluation of the change control in the PHENIX.
  • Evaluation and Approval of the CAPA in the PHENIX.
  • Implementation of CAPA related to sterility assurance.

Documentation

  • Write, review, approval of standard operating procedures related to sterility assurance function.
  • Review and approval of aseptic process simulation protocols, Execution records, and preparation of APS summary report.
  • Prepare, review, approval of Environmental monitoring trends, and summary reports.
  • Write and review change control forms to assess the impact of proposed changes.
  • Approval of standard operating procedures of user departments related to sterility assurance.

External Audits/Inspections:

  • Ensure the site is all-time readiness for audits in the sterility assurance aspect.
  • Actively involve global quality audit, regulatory inspections, and develop responses/CAPA for audit findings/observations by coordinating with cross-functional departments.

Training

  • To impart the training associated with Sterility Assurance

Qualification: B.Sc/M.Sc

Experience: 5-6 Years

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