Ravi Kumar Vendra

• Leading Quality control department
• Responsible for Analytical tech transfer
• Raw material and packing material release according to the plan.
• Finished and commercial batches are released.
• Responsible for stability studies.
• Manpower recruitment.
• Maintaining quality standards.
• Responsible for investigations OOS, OOT, LIR and deviations.
• Collaborating with regulatory teams to ensure quality control documentation for regulatory submissions, such as INDs, NDAs, and BLAs.
• Annual budget for preparation and utilizing the funds in an effective manner.
• Responsible for GLP practices in the lab.
• Implementation of change control and CAPAs.
• Responsible for making the laboratory inspection-ready for regulatory audits.

Led quality control department, ensuring compliance with established standards.

Managed analytical tech transfer and release of raw and packing materials as per schedule.

• Oversaw release of finished and commercial batches to meet production timelines.
• Conducted stability studies to guarantee product integrity over time.
• Supported regulatory affairs in preparation for ANDA submissions.
• Executed manpower recruitment to build a skilled quality control team.
• Maintained quality standards through rigorous investigations of OOS, OOT, LIR, and deviations.
• Prepared annual budget, effectively utilizing funds for departmental needs.

• Company Overview: (Sterile drug products)
• Planning and execution of Method validations for multiple dosage projects are like Injectable, complex molecules, ophthalmic and Raw materials.
• Responsible for Analytical method validation/ Verification and Method transfers in quality control department.
• Performing method feasibility studies for new methods and troubleshooting methods.
• Method development compliance.
• Method validation /verification protocols &Reports review.
• Cleaning method validations.
• Performing method equivalency studies if any method is deviating from official compendia methods.
• Conducting laboratory investigations.
• Optimization of Diluents compatibility study methods.
• Finalization of STP's for Drug products and Raw materials.
• Review of specifications for Drug product, API &Excipients on the current requirements declarations.
• Experience in recruitment of Analytical team
• Closely working with Business development team for ongoing projects progress and new projects initiation Monitoring outsources (Third party labs) tests validation activities for E& L
• (Sterile drug products)

• Headed analytical method transfer team.
• Planning and execution of Tech Transfer activities from the global sites.
• Hands on experience in stability studies.
• Investigating OOS, LIR and VIC's.
• Experience in Change Control (QMS)
• Experience in Lab ware LIMS.
• Having analytical experience in regulatory environment.
• Having experience in successfully facing regulatory audits by USFDA MHRA UK, TGA.
• Having certificate from waters as an 'Empower reviewer'.
• Providing on the job training for newly joined analysts.
• Experienced in the use of Ion Exchange Chromatography. (DIONEX)
• Experienced in the use of High-Performance Liquid Chromatographs (HPLC&UPLC), UV, IR, GC and Dissolution.
• Review of raw analytical data with respect to accuracy and adequacy.

• Analysis of Raw material, In-process Samples.
• Experienced in the use of HPLC, UV, IR, GC, and wet Analysis.
• Residual Solvents Analysis.
• Calibration of laboratory equipment.
• Preparation of Raw data work sheets.
• Experienced in Sampling from the Stores as per cGMP guidelines.

• Analysis of Raw materials, intermediates and finished products.
• Analysis of API by HPLC and GC
• Reaction monitoring by HPLC and GC.
• Preparation of Volumetric solutions and standardizations.
• Responsible for monitoring and maintaining reagents needed for testing requirements.
• Handled the High-Performance Thin layer chromatography, UV.
• Preparing SOP's and ROA.