Associate

Site L2-PDP-Team Member - Aseptic Monitoring
1. Filling Operations Aseptic Monitoring:

• Conduct daily checks on filling line operators to ensure adherence to SOPs and aseptic practices.

• 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.

2. Deviation Prevention & Investigation Support:

• Provide immediate corrective feedback to prevent deviation escalations during live production.

• Support investigations and root cause analysis by providing documented evidence of aseptic practices during specific production periods.

• Collaborate with QA and deviation teams to address aseptic non-conformances and implement corrective actions.

3. Aseptic Competency Assessments & Operator Training:

• 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.

4. Documentation & Compliance Reporting:

• 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.

Filling Operations Aseptic Monitoring:
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.

Deviation Prevention & Investigation Support:
Provide immediate corrective feedback to prevent deviation escalations during live production.
Support investigations and root cause analysis by providing documented evidence of aseptic practices during specific production periods.
Collaborate with QA and deviation teams to address aseptic non-conformances and implement corrective actions.
Aseptic Competency Assessments & Operator Training:
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.

Documentation & Compliance Reporting:
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.

Required Education Qualification: Bsc

Required Experience: 1 - 3 years