Srikanth Manchala

Experienced Quality Management Professional and certified ISO QMS Lead auditor by IRCA/CQI with demonstrated experience and expertise in QA, DQA of CDMP,API, Nutraceuticals & FR&D.

Excelled at setting up QA functions and DQA of CDMO, API-R&D facilities and exposure on formulation R&D of synthesized CDMO/API molecules.

Insightful Manager with experience directing and improving systems through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, trainings and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.

Targeting challenging assignments in Quality & Regulatory Management with a reputed & esteemed organization and an individual can work with all his skills and abilities.

• Handling and involving of multiple product development and analytical method development, validations and achieved best outcomes in view of consistence CQA's and robust analytical method and transferred to sites.
• Impurities and spectra review and recommendations for solvent recommendations, change in methodology and compositions as trouble shooting for development programme in HPLC, GC, Mass spectroscopy, NMR and wet chemistry.
• Involving in successful completion of CDMO projects development and Validations as part of technology transfer in appropriate timelines.
• Case studies and evaluation on process safety studies like Rapid screening device for thermal behavior exothermic and endothermic, DST, RSD, Minimum ignition temperature, powder expansion and MIE etc. and achieved successful outcome to support site teams while large scales.
• Analyzation of flow chemistry interpretation with product development requirements like flow reactions techniques in terms of critical reaction monitoring and best outcomes for scale ups.
• Successful handling of vendor evolution for impurity profile challenges and Nitrosamine's in critical raw materials, KSM's and API carryover. Genotoxic evaluation, elements and Nitrosamine's assessment to target the quality of product.
• Handled the Quality Risk Management for process and Nitrosamine's and elements and completed more than 15 Products in line with ICH-Q9 and derive the CAPA and mitigations for controls required.
• DMF and CEP filing support to RA for Regulatory filings, queries for DMF and CEP markets for more than 15 products with in timeframe.
• Played a vital role towards successful implementation of QMS (Change Management, CAPA, Deviation, OOS, market complaints & Investigation tool at Neuland labs Ltd.
• Successfully implemented the cleaning validation of multi product facilities to reach the MACO acceptance in different facilities and effective process validations in previous companies.
• Handling and involved in initiations of backup and audit trail of Empower and Standalone systems and multi software handling and GAMP 5 validations of SAP-QM & MM Module, ELN Chemia, Minitab, Investigation Procedure/s, Documentation Control Management, DMS (e-approval tool for document/s), track wise, eQAMS.
• Successful trainings on GxP programmer's across the sites and got results on operations.
• Proven results IPQA compliance, SOP compliance, Line clearance, process, cleaning validation and investigation support.

Certified ISO 9001:2015 QMS lead auditor by IRCA/CQI accredited (Certifiecate.No. IN/17934/196080, CQI-UDN-440013).