Suresh Varma Bhupati

Analytical and Manufacturing investigation support

• Lead the Investigations related to Analytical methods/ test results, Process and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Provide valuable information to drive the CAPAs.
• Performing day to day activities with Data Integrity Principles and Procedures

Continuous Improvement projects

• Develop and validate robust Analytical method for improvements and avoid potential challenges during release/stability testing.
• Providing scientific rationale/ justifying and outlining recommendations for changes to improvements in Analytical and production processes.
• Collaborate and Implement analytical / process improvement opportunities and provide corrective actions which can be cost effective, time saving, increase yield, maximize capacity, and decrease process variability while maintaining regulatory compliance.

Project support/ People development

• Technology transfer support to qualify analytical methods by method transfer, validation and verifications.
• Establish cleaning method limits and develop/validation analytical methods for quantification of Swab/rinse samples.
• Review and approval of technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancy and investigation.
• Risk assessments documents review and approval like, Elemental impurities/ nitrosamine impurities, instrument qualifications, EB and PV batches etc...
• Resolved conflict quickly to limit operational disruption and maintain positive, productive working environments.
• ·Ensure the compliance to cGMP/ cGLP, organizations procedures and practices
• Collaborated with cross-functional teams to maintain project progress.
• Monitored team performance to identify productivity improvement opportunities.
• Delegated tasks strategically and monitored progress for timely completion.
• Improved team morale and retention through recognition and reward programs.
• Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
• Defined clear targets and objectives and communicated to other team members.

Other activities

• Performed internal audits for better compliance.
• Performed effectiveness checks for instruments to meet 21 CFR 11 requirements.
• Support and faced FDA audits to explain the processes followed.
• Leachable and extractables study of container closer systems like rubber stoppers.
• Preparation, review and approval of SOP’s and Analytical Validation related guidelines.
• Monitoring of Instrument calibration due dates and performing of
• Responsible for qualification of instruments (IQ, OQ, PQ).
• Providing trainings on SOP's through continues oral and instructor led training.