Viral P. Patel

Pharmaceutical QC professional with the expertise and readiness to excel as Assistant General Manager Quality Control. Brings 24 years of progressive leadership in QC Microbiology, Chemical Testing, and Analytical Development within regulated biotechnology and pharmaceutical manufacturing environments. Currently managing end-to-end QC operations as Sr.

Manager overseeing microbiology, instrumentation, purified water systems, environmental monitoring, and management systems (QMS/CAPA/change control). Deep competency in regulatory compliance across global standards (cGMP, GLP, FDA, ICH, USP, EP) and a track record of leading teams through 9 successful regulatory inspections (USFDA, MHRA, ANVISA, WHO, and more) with zero critical findings. Skilled at research & development support, method validation, and technology transfer.

A hands-on coach and communicator who leads, mentors, and develops teams - reducing attrition from 80% to 10% and deviations by over 50%. Brings the ability to lead cross-functional operations with a strategic mindset and a commitment to scientific excellence. With 24 years of mastery well beyond the minimum required - brings not just compliance but deep institutional knowledge, regulatory credibility, and a proven capacity to uplift entire QC functions.

Sr. Manager – QC Microbiology, Chemical & Instrumentation - Lincoln Pharmaceutical Limited - Ahmedabad

(2016-09)

Lead multi-disciplinary QC operations across microbiology, chemical analysis, and instrumentation for a cGMP-compliant, multi-product non-sterile facility serving global regulated markets.

• Oversee all microbiological and chemical testing of raw materials, in-process samples, and finished products; ensure timely analysis and reporting against pharmacopoeial and internal specifications.
• Establish, validate, and maintain analytical testing methodologies (MLT, water methods, disinfectant efficacy, preservative efficacy, hold time validation) in compliance with USP, EP, and ICH guidelines.
• Supervise environmental monitoring programs for non-sterile facilities including air and surface sampling; maintain trending data for EM, water, and QMS.
• Drive QMS activities deviations, change controls, CAPAs, OOS/OOT investigations - achieving 100% closure within committed timelines using TrackWise.
• Plan, monitor, and execute calibration and qualification of instruments and equipment (HVAC, water systems, autoclaves, HPLC, UV, GC, FTIR, air samplers) as per schedule.
• Review and approve SOPs, specifications, analytical methods, and records; ensure alignment with revised Schedule M, WHO TRS 1044, and WHO TRS 1033.
• Ensure strict GLP compliance and ALCOA+ data integrity principles across all laboratory operations and documentation.
• Lead, mentor, and train QC team of 12-15 professionals; conduct analyst qualification and routine training per GLP schedule; reduced attrition from 80% to 10% within one year.
• Conduct GAP assessments and update procedures proactively ahead of regulatory inspections.
• Collaborate cross-functionally with QA, Manufacturing, R&D, and Regulatory Affairs to ensure robust analytical support for product development and commercial operations.
• Manage laboratory budgets, forecast expenditures, and allocate resources efficiently across QC functions.
• 9 Global Regulatory Inspections (USFDA, MHRA, ANVISA, WHO, Canada & more): Zero critical observations against QC Microbiology across all inspections.
• New Microbiology Facility: Established facility from the ground up - completed on schedule, fully regulatory-compliant, zero critical audit findings.
• 50%+ Reduction in Deviations: Achieved through systematic gap assessments, SOP revisions, and preventive quality measures.
• 100% CAPA Closure Rate: Streamlined OOS investigation and TrackWise workflows for on-time closure of all CAPAs.
• Wockstar Award: Recognized for quality initiatives (single-lot media procurement + club templates for water analysis) reducing rework costs and documentation turnaround by ~40%.
• Team Transformation: Reduced attrition from 80% to 10% through structured mentoring, training programs, and culture building.

Section In-Charge / Team Lead – QC Microbiology - Mylan Laboratories Ltd. - Ahmedabad

(2015-08 - 2016-09)

• Managed microbiology work planning, distribution, and day-to-day QC operations in a regulated generics manufacturing environment.
• Prepared and reviewed validation protocols, summary reports, and COAs; supervised change controls and incident management.
• Designed analytical testing procedures, specifications, and LIMS templates; performed MLT validation, water system qualification, and disinfectant efficacy studies.
• Contributed to internal audit team and maintained audit readiness for regulatory inspections.

Deputy Manager / Section In-Charge – QC Microbiology - Lincoln Pharmaceutical Ltd. - Ahmedabad

(2010-10 - 2015-08)

• Managed QC microbiology operations; reviewed and approved SOPs and analytical records to cGMP and regulatory requirements.
• Prepared and reviewed validation protocols, summary reports, and COAs; supervised CAPA and change control processes.
• Provided technical training to microbiologists; managed culture library and in-house reference isolate library.

Officer-I – QC Microbiology - Sun Pharmaceutical Industries - Dadra

(2010-09 - 2012-10)

• Managed microbiological testing; performed criticality-based sampling site selection and water method validation (R2A).
• Reviewed and approved SOPs per cGMP standards.

Executive QA – Validation - Claris Life Sciences Ltd. - Ahmedabad

(2009-10 - 2010-09)

Executive QA – Validation - Ipca Laboratories - Athal

(2009-02 - 2009-10)

Executive Microbiology – QC - JB Chemicals & Pharmaceuticals - Panoli

(2008-07 - 2009-02)

Officer – QC Microbiology - Medley Pharmaceutical Ltd. - Daman

(2007-06 - 2008-06)

Officer – Microbiology - Famy Care Ltd. - Sarigam

(2005-08 - 2007-06)

Junior Research Officer - Jai Research Foundation - Vapi

(2002-10 - 2005-08)

M.Sc. - Microbiology - North Gujarat University (2001)

B.Sc. - Zoology, Microbiology & Chemistry - North Gujarat University (1999)