Yogesh Rayate
Vadodara
Summary
Laboratory Quality Control Specialist experienced in raw materials, packaging, finished products, and stability studies. Achieved compliance by leading investigations into unexpected test results and deviations, while managing various lab software and quality systems. Focused on resource optimization and coordination with production, R&D, and supply chain to meet regulatory requirements.
Overview
16
16
years of professional experience
Work History
QC Manager
Innoxel Lifescience Pvt. Ltd
Vadodara
10.2024 - Current
- Led and managed a team of 12 quality control professionals in a pharmaceutical laboratory.
- Planned and executed raw material, packing material, analytical method transfers, method verifications, and method validations to ensure compliance with regulatory standards.
- Planned and executed analytical method transfers, method verifications, and method validations according to regulatory requirements.
- Preparation and review of specifications, method of analysis of Finished product, Stability, Raw Material and Packing material.
- Preparation and review of analytical protocols and reports (Analytical method validation/verification/transfer, method equivalency etc.).
- Technical assessment of projects (screening, pipeline, and development stages) & literature search.
- Preparation of analytical technical documents for dossier/ Regulatory submissions of projects.
- Assisting and resolving technical queries rose during analytical method validation/ verification/ transfer activities & regulatory submissions.
- Review of drug master files (DMFs).
- Investigated laboratory incidents, OOS results, OOT results, OOC results, and deviations; implemented corrective and preventive actions (CAPA) to maintain quality assurance.
- Wrote and reviewed standard operating procedures (SOPs).
QC Manager
Baroque Pharmaceuticals Private Limited
Khambhat
05.2019 - 10.2024
- Direct a comprehensive, 45-member Quality Control function, overseeing multi-functional operations across AMV/AMT, Finished Products (FP), Raw Materials (RM), Packaging Materials (PM), GLP, LIMS, QMS, and Documentation
- Approval of analytical protocols and reports (Analytical method validation/ verification/ transfer, method equivalency etc.).
- Review and approval of specifications, method of analysis, SOPs.
- Orchestrated end-to-end strategic planning and technical execution of new laboratory setup, managing CAPEX allocation, instrument procurement, installation, and qualification (DQ/IQ/OQ/PQ), ensuring harmonization of SOPs and IOCPs across testing streams.
- Investigated laboratory incidents, OOS results, OOT results, OOC results, and deviations; implemented CAPA to address and mitigate issues.
- Assisting and resolving technical queries rose during analytical method validation/ verification/ transfer activities & regulatory submissions.
- Review of analytical technical documents for dossier/regulatory submissions of projects.
- Prepared and reviewed dissolution f1 and f2 reports and dissolution body reports.
- Key member of Internal and outside laboratory Audit Team.
- Technical assessment of projects (screening, pipeline, and development stages) & literature search.
- Review of drug master files (DMFs).
- Standardized operating procedures to enhance consistency across all processes.
QC Assistant Manager
Micro Labs Limited
Verna
11.2013 - 05.2019
- Led and managed a team of 41 quality control professionals in a pharmaceutical laboratory.
- Planned and carried out In-process, Finished product, Process validation, analytical method transfers, method verifications, method validations according to regulatory rules.
- Investigated OOS/OOT/deviation events, managed change control procedures, and implemented CAPAs in quality control lab.
- Oversaw quality control activities by allocating analysis of in-process, process validation, cleaning validation, and finished product samples to analysts based on priority.
- Provided training to all Quality control associates regarding OOS investigation & GLP.
- Reviewing raw data, final reports and issuing COAs to QA.
- Ensuring that the product analyzed by section staff is as per requirements.
- Implemented GLP to maintain highest level of compliance.
- Conducting self audit quality control.
- Efficiently monitored calibration of analytical instrument.
- Implemented strategies to reduce costs effectively.
Quality Control Officer
Cipla Limited
Verna
03.2010 - 10.2013
- Monitored ANDA batch stability and analyzed trending results for regulatory compliance.
- Reviewed analytical data for accuracy and reliability of results.
- Analyzed in-process, finished product, and raw material to meet quality standards.
Education
M.Sc. - Chemistry
Babasaheb Ambedkar Marathwada University
Aurangabad, Maharashtra01-2009
B.Sc. - Chemistry
Arts, Science and Commerce Colledge
Lasalgaon, Nashik, Maharashtra01-2006
Skills
- Regulatory compliance
- Analytical method validation
- Analytical Method Transfer
- Finished Product
- Stability Studies
- Raw Material and Packing Material
- GLP and QMS management
- Laboratory Information Management
Languages
- English
- Hindi
- Marathi
Disclaimer
I Yogesh Rayate hereby declared that all above information about my profile hold true.
Timeline
QC Manager
Innoxel Lifescience Pvt. Ltd
10.2024 - Current
QC Manager
Baroque Pharmaceuticals Private Limited
05.2019 - 10.2024
QC Assistant Manager
Micro Labs Limited
11.2013 - 05.2019
Quality Control Officer
Cipla Limited
03.2010 - 10.2013
M.Sc. - Chemistry
Babasaheb Ambedkar Marathwada University
B.Sc. - Chemistry
Arts, Science and Commerce Colledge