P.RAJESH PANDI

• Participating in batch planning meetings to ensure timely testing and release of reports.
• Handling regulatory and internal audits.
• Continuously evaluating laboratory practices for compliance and improvements in operational excellence.
• Reviewed and updated standard operating procedures regularly to reflect latest industry best practices and regulatory requirements
• Managed validation and calibration of laboratory equipment, ensuring optimal performance at all times
• Played a pivotal role in achieving regulatory compliance during audits through thorough documentation practices and adherence to guidelines

• - Conducting site manufacturing investigations and initiating Corrective and Preventive Actions (CAPA) in accordance with requirements.
- Executing Quality Audits at manufacturing sites to ensure microbiology lab compliance.
- Developing new Standard Operating Procedures (SOPs) and validation protocols.
- Handling both regulatory and internal audits.
- Overseeing the Media Fill simulation process, classifying interventions, and integrating them into the media fill program.
- Utilizing Failure Mode and Effects Analysis (FMEA) for root cause analysis of critical issues such as environmental monitoring deviations and media fill failures.
- Leading a team of 25 members, fostering high levels of competence and efficiency.

• Conducted Bio-burden, MLT, and BET tests on incoming raw materials, intermediates, stability, and finished product samples. Executed sterility tests on finished products and stability samples.
- Monitored environmental conditions in Aseptic and controlled areas, including Non-Viable monitoring in classified zones.
- Prepared media, performed Growth Promotion Tests (GPT), and maintained media stocks. Isolated and maintained cultures, and conducted identification tests using VITEK.
- Sampled and analyzed water (WFI, PW, Raw, Potable water).
- Validated Steam heat sterilizers, incubators, and deep freezers.
- Participated in Aseptic media fill simulations and interventions. Engaged in HVAC system area qualification.

• Ensured quick resolution of technical issues by collaborating closely with support teams, minimizing downtime and impact on project timelines.
• Managed inventory of lab supplies, ensuring adequate stock levels to prevent delays in project timelines.
• Achieved consistent compliance with regulatory standards by staying current on industry trends and best practices related to microbiology testing.

•Conducted Bio-burden, MLT, and BET tests on raw materials, water, intermediates, stability, and finished products.
- Executed environmental monitoring in controlled areas.
- Managed media preparation, GPT, and media stock. Carried out culture isolation and storage maintenance.