Vilas Ingole
Assistant Manager-qa @USV PRIVATE LIMITED
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WORK HISTORY
Assistant Manager-qa @USV PRIVATE LIMITED
Daman, IN
Investigations for Out of Specification (OOS) & Out of Trend (OOT) results to identify the root cause (Lab error vs. Manufacturing issue)(QC as well as Microbiology).Managing laboratory deviations and implementing CAPA (Corrective and Preventive Actions) to prevent recurrence.Ensuring the lab is always ready for inspections from agencies like the USFDA, MHRA, ANVISA, WHO.Deep understanding of 21 CFR Part 11 (Electronic Records).Overseeing the IQ/OQ/PQ (Installation, Operational and Performance Qualification) of high-tech lab equipment/Instruments.Ensuring that analytical methods are correctly transferred from R&D to the Quality Control (QC) lab.Training lab chemists on SOPs, safety protocols and new regulatory guidelines.Periodically reviewing electronic audit trails of laboratory instruments to ensure no unauthorized changes or deletions occurred.Writing, reviewing and updating Standard Operating Procedures to reflect current global standards.
EDUCATION
Yashwant Junior college, Ahmedpur, Dist. Latur
HSC
Jay Bharat Vidhyalay, Jawala (BK), Dist. Hingoli Maharashtra.
SSC
Sant Gadge Baba Amravati University, Amravati
Bachelor of Pharmacy, Pharmacy
Savitribai Phule Pune University
Master of Pharmacy in Quality Assurance Techniques, Quality Assurance Techniques
ABOUT VILAS INGOLE
A dedicated pharmaceutical quality assurance professional with over 12 years of experience, currently serving as Assistant Manager-QA at USV PRIVATE LIMITED. Proficient in managing laboratory investigations for Out of Specification (OOS) and Out of Trend (OOT) results, laboratory deviations, and implementing Corrective and Preventive Actions (CAPA) to ensure compliance with global regulatory standards. Skilled in 21 CFR Part 11 compliance, lab QA and overseeing IQ/OQ/PQ of high-tech lab instruments, ensuring consistent operational excellence. Committed to maintaining regulatory readiness for inspections by agencies such as USFDA, MHRA, and WHO. Demonstrates expertise in transferring analytical methods from R&D to QC labs and training laboratory chemists on SOPs, safety protocols, and regulatory guidelines. Passionate about fostering a culture of compliance, quality and continuous improvement in the pharmaceutical industry.
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