Sunil Ojha

• Responsible for ensuring cGLP-compliant QC laboratory operations, documentation, and adherence to regulatory requirements.
• Reviewing and qualifying working standards and maintaining an effective column management system.
• Preparing and reviewing worksheets, raw data, and analytical reports as per SOPs and cGMP/cGLP guidelines.
• Conducting daily laboratory rounds to ensure compliance, data integrity, and good laboratory practices.
• Reviewing analytical results of raw materials, intermediates, in-process, and finished products.
• Handling QMS activities including change controls, deviations, incidents, and ensuring timely documentation of quality events.
• Supporting laboratory investigations, including root cause analysis, and reviewing instrument logbooks.
• Providing training and guidance to junior staff to ensure adherence to quality systems and laboratory procedures.
• Handling regulatory and customer audits including USFDA, Health Canada, European authorities, internal, and vendor audits.

• GLP sectional responsibilities including review of qualification data.
• Maintained worksheets/raw data and ensured compliance with SOPs.
• Conducted routine analysis of raw materials, intermediates, and finished products.
• Managed deviations, change controls, and laboratory investigations.
• Provided training and audit preparation support.

• Conducted audit trail reviews of standalone and CDMS software.
• Reviewed in-process materials, finished products, R&D samples, and raw materials.
• Ensured compliance with GLP and calibration of analytical instruments.
• Conducted cleaning method validations and monitored reserved samples.

• Performed API and formulation analysis.
• Conducted timely analysis of raw materials, finished products, and API samples.
• Maintained cGMP/cGLP compliance and documentation.
• Conducted internal audits and corrective action implementation.