ASSISTANT MANAGER

• Conduct daily checks on filling line operators to ensure adherence to SOPs and aseptic practices (SOP 146).
• Monitor aseptic technique execution, including gowning procedures, material transfers, and interventions, to maintain sterility assurance.
• Perform routine verification of filling operations and changeovers, ensuring all actions align with procedural requirements.
• Conduct weekly CCTV batch reviews to proactively identify non-conformance trends and prevent potential deviations.
• Maintain annexure for real-time aseptic observations, documenting compliance findings and operational best practices.
• Record and track Out-of-Control (OOC) incidents, ensuring corrective actions are taken to prevent recurrence.

• Provide immediate corrective feedback to prevent deviation escalations during live production.
• Support investigations and root cause analysis by providing d/o/cumented evidence of aseptic practices during specific production periods.
• Collaborate with QA and deviation teams to address aseptic non-conformances and implement corrective actions.

• Lead biannual aseptic performance evaluations for all filling operators, assessing their ability to execute aseptic operations per SOPs.
• Work closely with QA and QCM teams to conduct competency simulations and provide training on aseptic techniques.
• Document assessment outcomes and identify training needs for individual operators to enhance their aseptic execution skills.

• Maintain and update annexures for CCTV reviews, real-time observations, and Out-of-Control (OOC) incidents.
• Ensure proper documentation of all aseptic monitoring activities, making records readily available for regulatory inspections and internal audits.
• Contribute to continuous improvement by providing insights from aseptic monitoring to refine SOPs and aseptic process controls

• Conduct daily checks on filling line operators to ensure adherence to SOPs and aseptic practices (SOP 146).
• Monitor aseptic technique execution, including gowning procedures, material transfers, and interventions, to maintain sterility assurance.
• Perform routine verification of filling operations and changeovers, ensuring all actions align with procedural requirements.
• Conduct weekly CCTV batch reviews to proactively identify non-conformance trends and prevent potential deviations.
• Maintain annexure for real-time aseptic observations, documenting compliance findings and operational best practices.
• Record and track Out-of-Control (OOC) incidents, ensuring corrective actions are taken to prevent recurrence.

• Provide immediate corrective feedback to prevent deviation escalations during live production.
• Support investigations and root cause analysis by providing d/o/cumented evidence of aseptic practices during specific production periods.
• Collaborate with QA and deviation teams to address aseptic non-conformances and implement corrective actions.

• Lead biannual aseptic performance evaluations for all filling operators, assessing their ability to execute aseptic operations per SOPs.
• Work closely with QA and QCM teams to conduct competency simulations and provide training on aseptic techniques.
• Document assessment outcomes and identify training needs for individual operators to enhance their aseptic execution skills.

• Maintain and update annexures for CCTV reviews, real-time observations, and Out-of-Control (OOC) incidents.
• Ensure proper documentation of all aseptic monitoring activities, making records readily available for regulatory inspections and internal audits.
• Contribute to continuous improvement by providing insights from aseptic monitoring to refine SOPs and aseptic process controls

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