Lead - QA- Documentation & Validation, Capsules (Quality)

2 weeks ago


Pithampur, Madhya Pradesh, India ACG Full time
Primary Responsibilities

Strategic Planning Activities:

  • Plan & ensure the FT preparation as per Production requirement in a shift
  • Ensure GMP and gowning and safety
  • Ensure shift handover/takeover on the shop floor and hold accountability for any failures/challenges in the previous shift
  • Ensure compliance to the daily dipping schedule for FT preparation, color change, ZMICs for specific requirements for all upcoming batches
  • Ensure shade compliance on Mac bath to ensure zero productivity loss in account of color shade variation
  • Review and ensure 100% compliance to documentation practices for daily record (weighing balance, MM batch record, auto viscosity verification, load cell verification, cold room cleaning, Temp. monitoring, CTQ monitoring, observation audit Checklist monitoring)
  • Check preservative traces for prepared FT to ensure zero cross contamination and subsequent productivity loss
  • Ensure 100% online documentation by leveraging Digitalisation EBMR/ RFID for all processing BMR document
  • Execute Mac Bath Calibration twice in shift to ensure accuracy of the equipment
  • Recipe Verification for new shades in order to achieve FTR wrt to capsule shade
  • Verify viscosity of each Feed Tank prepared
  • Verify correctness of color preparation activity and documents
  • Optimise the consumption of gelatin losses and Water
  • Ensure adherence to safety guidelines/ Environment Management System - ISO / Occupational Health and Safety - ISO , c-GMP, regulatory & statutory compliances, TPM and other applicable norms

Internal process

  • Preparation of various reports
  • Monitor and review Multiskilling initiatives in order support Departmental goals


People development

  • Ensure proper manning and shift handling, shift activities
  • Effective training to the operators with evaluation for compliance
  • Effective manning to utilization of available sources

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