Manager- Sterility Assurance

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