The founder is an Industry veteran with proven track of 30-years in quality system, determining & deploying compliance strategy and an accomplished leader in Design, C&Q and reverse engineering.
. University topper, M. Sc. (Chemistry), involved in Ph.D program as JRF on Phytochemical investigation of medicinal plants of Macaranga family under UGC and certified in Clinical Trial Management from ICRI Bombay.
. Over 27 years of proven track record in Hochest, Pfizer, Lupin, Ranbaxy, Strides-Aspen, Agila, Cipla in determining & deploying compliance strategy for sterile & OSD leading for EU, USFDA, WHO, PIC/S approvals.
. Highly skilled, result oriented accomplished team Leader from front in Design, C&Q, reverse engineering of Greenfield projects for potent drugs involving Platform technology and ASTM 2500E risk based approach.
. Expertise in facilitating Process validation, Cleaning validation, Operational excellence and Quality culture.
. Technical due diligence and GAP analysis, implementing CAPA and strategic remediation to import alert.
. Investigated for OOS, OOT, failure RC, data integrity breach (ALCOA) and installed policy for fail-proof GDP.
. Established GMP Trainer and Coach as per ICH, EudraLex, CFR, clean room practice guidelines, behavioural GMP, ALCOA, computer system validation with proven track in India, Kenya and China.
. Instituted the customised internal and supplier quality audit programs and technology transfer models and acumen in skilled staff recruitment.
. Tarun is an M. Sc. In Microbiology and doctorate from G. K. University, Hardwar.
. Over 29 years in the leading MNC, Lupin, Tabuk Pharma, Oman Pharma,Ranbaxy, Baxter, Claris, Amneal, Square Pharma in implementing and enhancing quality system for sterile & OSD leading EU, USFDA, MHRA, ANVIZA audits
. Highly talented, analytical acumen and result oriented accomplished team leader in Design, C&Q, of Greenfield projects for potent drugs involving barrier technology and containment.
. Expertise in harmonization of the systems, policies, process, and work culture across various plants by standardization and technology transfer and microbial validations.
. Leader in investigation management for OOS, OOT, failure, data integrity breach (ALCOA), CSV, etc.
. Established GMP Trainer and Coach as per ICH, EudraLex, CFR, computer system validation, aseptic practice, data integrity with proven track.
. Prema is a Pharmacy graduate, certified in management from MILT.
. Over 30 years of proven track record in Strides, Mysore Pharma, Caryl lab and Intra lab in implementing and enhancing quality system for sterile & OSD leading for EU, USFDA, WHO, PIC/S, TGA approvals.
. Extremely talented, analytical acumen and result oriented accomplished team leader in Design, C&Q, of Greenfield projects for potent drugs involving barrier technology and containment.
. Leader in investigation management for OOS, OOT, failure, data integrity breach (ALCOA), CSV, etc.
. Established GMP Trainer and Coach as per ICH, EudraLex, CFR, computer system validation with proven track.
. Mahesh is an M.S Chemical Engineering, NJIT, Newark,NJ. Published three articles in the Journal of Drug Development and Industrial Pharmacy
. Over 10 years of proven track record in US in Pfizer Biotech, Ben Venue Laboratories, Sanofi Pasteur and Genentech in bio-pharmaceutical validation and process engineering
. Facility and Engineered Systems design, installation, commissioning, qualification and operation for Pharma and Bio- Pharma industry to optimize throughput while meeting compliance requirements.
. Lead in the basic engineering support in sterile manufacturing for load evaluation and development for cleaning of filling components, CIP and COP methods, HPHV, Tunnel and DHS.
. Established GEP Trainer for pharmaceutical & biopharmaceutical processes, validation and qualification.
. Academic – M. Sc in Chemistry; Certified for Computer system validation.
. Over 16 years of proven track record in Pfizer health care, Orchid Chem & Pharma, VKT Pharma, Essar Steel in determining and deploying compliance strategy in QC, microbiology, AMV, technology transfer.
. Well versed on review of electronic records, electronic signatures and audit trails analytical instruments, LIMS configuration, SDMS, Custom fields, CSV, SAP, e-signatures management, Track wise applications, etc.
. Performed gap analysis as part continual improvements with respective procedures against practices. Involved in investigating Incidents, deviations, OOS, OOT and Events, Change control management, and CAPA.
. Consultancy services for OOS’s review as part of US FDA warning letter response, data integrity audit for DMF submissions, GAP assessment as a part of pre-inspection of US FDA, contract testing laboratory, CSV.
. Yogesh is an M. Sc. in Microbiology and doctorate from M.L.S. University, Udaipur
. Over 17 years in the leading MNC, Pfizer Health Care, Merck Limited, Aspiro Pharma (Hetero Drugs) and CRO Vimta Labs in implementing and enhancing quality system for sterile & API leading USFDA, MHRA, INVIMA audits.
. Highly talented, analytical acumen and result oriented seasoned Microbiologist accomplished in progressive Quality improvement experience in Lab Operations & Quality Compliance and team leading
. He has good understanding about regulatory inspections, handling &management harmonization of the systems, policies, process, technology transfer and microbial validations and SAL.
. Experience in Lean Concept-Operations & Cost optimization, Addressing of microbial contamination issues,
. Internal and external audits, RCA, implementing CAPA and deployment of effective clean room practices.
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