Rutuja Dhemare Email & Phone Number

Experienced QA Microbiologist with a solid background in maintaining quality control within pharmaceutical manufacturing environments. Proficient in microbiological testing methodologies, including sterility testing, endotoxin testing, environmental monitoring, and microbial identification. Skilled in executing and documenting validation protocols and implementing corrective and preventive actions (CAPA) to ensure product safety, compliance, and efficacy. Adept at collaborating with cross-functional teams to drive continuous improvement initiatives and ensure alignment with Good Manufacturing Practices (GMP). Diligent, detail-oriented, and committed to maintaining the highest standards of quality and regulatory compliance in pharmaceutical production processes.

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  Quality Assurance Officer

  Cipla

  Jun 2023 - Present - Goa, India

  •Conducting microbiological testing of raw materials, intermediates, and finished pharmaceutical products to ensure compliance with regulatory standards and specifications.•Performing environmental monitoring of production areas and utilities to detect, control, and prevent microbial contamination, ensuring a sterile environment.•Executing sterility and endotoxin testing following established procedures, protocols, and Good Manufacturing Practices (GMP) to meet regulatory requirements.•Investigating and documenting deviations from standard procedures, conducting thorough root cause analysis, and implementing corrective and preventive actions (CAPA) to avoid recurrence.•Collaborating with manufacturing and quality control teams to support continuous improvement initiatives, resolve quality-related issues, and maintain compliance with industry regulations.•Maintaining accurate, detailed, and up-to-date records of all microbiological testing activities and documentation in accordance with regulatory standards and audit requirements.