Manager- Sterility Assurance (15h Left)

Job Responsibilities :

1. 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.

2. Assure contamination control measures and monitoring are in place to guarantee sustainable environmental monitoring performance and drives the implementation of corrective / preventive actions.

3. Challenge technical and scientific aspects of facilities design and aseptic principles with Technical Services, Quality, production to increase quality standards.

4. Oversees aseptic validations and revalidation activities, including but not limited to Aseptic process Simulation Studies.

5. Enhance quality culture and practices through routine shop floor GEMBAs (process observations) and coaching / mentoring to ensure understanding of sterility assurance at all levels.

6. 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.

7. Perform microbiology and EM / PM investigations, impact assessments as part of deviation and investigations.

8. Execute gap assessments for sterility assurance against established standards and procedures.

9. Identifies and delivers continuous Sterility improvements.

10. Able to influence shop floor practices to elevate Quality Culture.

11. 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.

12. Develop and implement a contamination control strategy encompassing all aspects of manufacturing including Facility, Utility, Process, Material, Personnel controls.

13. Actively contributes and prepares the area for Inspections.

14. Responsible to defend Sterility Assurance & Aseptic practices specific procedures during Internal and External Regulatory Audits.

15. Responsible for audit responses and adherence to commitment timelines.

16. Responsible for supporting all key Investigations related to Sterility Assurance of manufactured Product and adverse environmental trends.

17. Hold weekly / monthly Sterility Assurance task force meetings to discuss issues and targets.

18. 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