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Manager- Sterility Assurance

Manager- Sterility Assurance

ConfidentialBaddi, India
6 days ago
Job description

Job Responsibilities :

  • Oversight of compliance with respect to Sterility Assurance to ensure alignment to the Site, Global and Regulatory requirements, including but not limited to : Aseptic Practices, Environmental Monitoring, Cleaning & Sanitization, Sterilization, Media Simulation, Change Over Controls, Clean Utilities, Gowning & Personnel Flow.
  • Assure contamination control measures and monitoring are in place to guarantee sustainable environmental monitoring performance and drives the implementation of corrective / preventive actions.
  • Challenge technical and scientific aspects of facilities design and aseptic principles with Technical Services, Quality, production to increase quality standards.
  • Oversees aseptic validations and revalidation activities, including but not limited to Aseptic process Simulation Studies.
  • Enhance quality culture and practices through routine shop floor GEMBAs (process observations) and coaching / mentoring to ensure understanding of sterility assurance at all levels.
  • Impart trainings on Aseptic Techniques / behaviors with emphasis on aseptic techniques during manufacturing operations, gowning techniques, clean-room behavior, slow and deliberate movements throughout the process, disinfection, and sanitization practices.
  • Perform microbiology and EM / PM investigations, impact assessments as part of deviation and investigations.
  • Execute gap assessments for sterility assurance against established standards and procedures.
  • Identifies and delivers continuous Sterility improvements.
  • Able to influence shop floor practices to elevate Quality Culture.
  • Provide guidance and technical support related to Sterility Assurance for project planning, qualification, and implementation throughout the entire project life cycle to guarantee quality and regulatory compliance.
  • Develop and implement a contamination control strategy encompassing all aspects of manufacturing including Facility, Utility, Process, Material, Personnel controls.
  • Actively contributes and prepares the area for Inspections.
  • Responsible to defend Sterility Assurance & Aseptic practices specific procedures during Internal and External Regulatory Audits.
  • Responsible for audit responses and adherence to commitment timelines.
  • Responsible for supporting all key Investigations related to Sterility Assurance of manufactured Product and adverse environmental trends.
  • Hold weekly / monthly Sterility Assurance task force meetings to discuss issues and targets.
  • Responsible for Sterility and Aseptic review prior to batch release.

Skills Required :

  • Extensive expertise in contamination control, sterilization principles, aseptic techniques, and environmental monitoring within a pharmaceutical manufacturing context. This includes a strong understanding of relevant regulations and industry best practices.
  • In-depth knowledge of aseptic processing principles, validation requirements (including media fills), and associated risk assessment methodologies.
  • Thorough understanding of cleaning and sanitization procedures for cleanrooms and equipment, including agent selection and validation.
  • Solid foundation in microbiology principles and experience in conducting investigations related to microbial contamination, environmental excursions, and deviations.
  • Familiarity with quality management systems, deviation management, change control, CAPA (Corrective and Preventive Action), and risk management processes.
  • Meticulous approach to ensure adherence to strict sterility and aseptic standards.

    • Qualification : M.Sc (Microbiology / Biotechnology)

    Experience : 10-15 Years

    Skills Required

    contamination control, Change Control, deviation management , Environmental Monitoring

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    Manager • Baddi, India