Lead: Sterility Assurance Group

2 months ago

Dera Bassi, India Panacea Biotec Full time

To lead SAG team for monitoring and implement sterility assurance program in aseptic area and as well as in microbiological aspects in other areas like microbiology lab.

Preparation and review of contamination control strategy (CCS) document at site. To ensure the implementation of recommendations as per the CCS.

Ensure to monitor the aseptic behavior and practices of all aseptic operators.

Strengthen the overall sterility assurance activities to meet the increasing regulatory requirements of pharmaceutical quality systems.

Ensure scientific decision making in the management related to sterility assurance.

To review the aseptic operator qualification and disqualification process.

Responsible for aseptic behaviors and practices review through CCTV or Physical review, trending of observations and suggestions for corrective & preventive actions

Review of smoke studies of aseptic area, reporting the observations and following up for the corrective actions.

Review of media fill and oversight during execution. Ensuring all the interventions are performed aseptically, operator behavior during media fills, materials sanitization and transfer practices.

Review of QMS (Change control/deviation/OOS) which is directly/indirectly impact on sterility assurance. Provide inputs during change control form review and investigation review.

Impart trainings on Aseptic behaviors and practices with emphasis on patient and product safety. Also Implementation of practical trainings related to aseptic activities.

Oversees in performing the Risk Assessment & Mitigation plan with respect to sterility assurance, men and material movement etc. in production & other aseptic areas like microbiology lab.

Suggest and implement continuous improvement plans especially in the area of validation and sterility assurance.

To prepare and review technical and other developmental training programs related sterility assurance program.

  • Lead: Sterility Assurance Group

    2 months ago

    Dera Bassi, India Panacea Biotec Full time

    To lead SAG team for monitoring and implement sterility assurance program in aseptic area and as well as in microbiological aspects in other areas like microbiology lab.Preparation and review of contamination control strategy (CCS) document at site. To ensure the implementation of recommendations as per the CCS.Ensure to monitor the aseptic behavior and...

  • Lead: Sterility Assurance Group

    2 months ago

    Dera Bassi, India Panacea Biotec Full time

    To lead SAG team for monitoring and implement sterility assurance program in aseptic area and as well as in microbiological aspects in other areas like microbiology lab. Preparation and review of contamination control strategy (CCS) document at site. To ensure the implementation of recommendations as per the CCS. Ensure to monitor the aseptic behavior and...

  • Lead: Sterility Assurance Group

    2 months ago

    bassi, India Panacea Biotec Full time

    To lead SAG team for monitoring and implement sterility assurance program in aseptic area and as well as in microbiological aspects in other areas like microbiology lab.Preparation and review of contamination control strategy (CCS) document at site. To ensure the implementation of recommendations as per the CCS.Ensure to monitor the aseptic behavior and...

  • Lead: Sterility Assurance Group

    2 months ago

    bassi, India Panacea Biotec Full time

    To lead SAG team for monitoring and implement sterility assurance program in aseptic area and as well as in microbiological aspects in other areas like microbiology lab. Preparation and review of contamination control strategy (CCS) document at site. To ensure the implementation of recommendations as per the CCS. Ensure to monitor the aseptic behavior and...

  • Senior Sterility Assurance Manager

    3 weeks ago

    bassi, India Panacea Biotec Full time

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