Sr.Manager / DGM - Sterility Assurance

Role Overview: As a Senior Manager / DGM - Sterility Assurance at our Halol - Vadodara location, you will be responsible for overseeing the Sterility Assurance and QMS elements for Sterile manufacturing Units. Your role will involve handling Regulatory Audit Queries and ensuring the implementation of contamination control strategies in compliance with regulatory standards. Key Responsibilities: - Own the Aseptic process simulation program of the site, including protocol development, operators training, intervention qualification program, and Trending analysis. - Develop and enhance the Sites Contamination Control Strategy to ensure robustness and continuous improvement. - Lead the Sterility Assurance committee for the site and review/approve the Microbiological environmental monitoring program. - Guide investigations of contamination-related non-conformance events and provide technical input for microbiological method transfers. - Act as a subject matter expert on sterility assurance during regulatory inspections, audits, and cross-functional initiatives. - Support inspection preparation and execution during health authority on-site inspections as an expert in Sterility Assurance. - Drive harmonization of sterility assurance programs across different sites and provide mentoring leadership to build capability in Sterility assurance. - Offer technical support for significant sterility assurance investigations, identify root causes, and implement corrective actions. - Collaborate with operations and QC micro lab for designing and delivering training programs on aseptic processing principles. - Mentor and develop junior sterility assurance staff and site SMEs to enhance technical expertise within the organization. - Build effective working relationships with internal and external stakeholders to ensure the success of sterility assurance. Qualification Required: - M.SC / B.Pharm / M.Pharma - Minimum 15 years of experience in Sterile / Regulatory Plants (Note: Additional details about the company were not provided in the job description.),