Specialist – Quality Assurance
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.
Actively participate in Centre of excellence Sterility Assurance meetings & implement initiatives at Shantha for both Medchal and MRP sites.
Actively participate in monthly site sterility assurance meetings and deployment of SA action plan in the site.
Provide guidance and support to customers related to Sterility Assurance programs.
To perform gap assessment for sterile global quality directives and ensure the implementation of developed mitigation plan.
To ensure QC-Microbiology lab compliance including method validations and practices.
Involve in identification and analysis of risks, evaluation, communication and documentation of risks and implementation of mitigation plans to identified risks.
Support the QRM activities by ensuring the availability of required resources, approval of CAPEX/OPEX (if any).
Actively involve and guide the team in investigations related to failure in sterility, APS, EM, clean utilities monitoring system and microbial related failures.
Ensure adherence to the annual aseptic process simulation schedule.
To participate and assist where required in internal/external audits respect to Manufacturing, QC microbiology and sterility testing area.
Support Head-Quality assurance as required in all the tasks assigned and delegated.
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.
Responsible for implementation of Global Documents at Site.
Review, approval and final authorization of GMP documents like
SOP, STP, Specifications, protocols, summary reports, Risk assessments, forms etc.
Quarterly and annual summary reports of environmental monitoring and clean utilities monitoring system for both Medchal and MRP sites.
Aseptic process simulation protocols and summary reports for both Medchal and MRP sites.
Qualification, Validation and Sterilization grade filter validation
Ensure the site is all time readiness for audits.
Actively involve global quality audit, regulatory inspections and develop responses/CAPA for audit findings/observations by coordinating with cross functional departments.
To impart the trainings associated to Sterility Assurance.
To ensure the training needs to the staff as necessary with respective to sterility assurance.
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