Dr. Shruti Bhat- Leader Pharmaceutical R&D.
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Shruti's Leadership accomplishments in International Operations-
Operational Expertise :
Expert with facility design and quality compliance for a variety of dosage forms including tablets, capsules, pellets, MUPS, syrups, injections, powders, ointments, creams, gels, medicated gauzes/ bandages, eye drops etc.
Expert with facility design and compliance measures for more than 21 disease areas including different antibiotics, steroids, enzymes, oncology, immune-suppressants, narcotic pain killers, anti-TB, dietary supplements, vitamins & nutritional supplements, probiotics, NHP (herbal) and biotech based products etc.
Expertise with facility designs complying to- Process layout, Line function and Fixed position layouts.
Development of Global Operations Strategy for dynamic and mid-sized life science companies.
Specialist in USFDA's Quality-by-Design (QbD) technique through Production, QA , regulatory, R&D and project divisions. Learn more on QbD...
Leadership in Operations:
Led Clinical Manufacturing department, production planning and scheduling in multi-dosage forms, multi-products, process and line function facilities. Excellent with process optimization and value stream mapping to enhance productivity and reduce wastages.
Conducted Equipment planning, Capital Budgeting and “Rationing” during facility expansions/ up gradations.
Led Supply chain management functions viz. Purchase, negotiations, contracts, vendor development, vendor approval, vendor ratings, warehouse stocking (EOQ, ABC and VED analysis) and material requirement planning (Linear programming and MRP).
Successfully led external international facility audits viz. USFDA, Health Canada, Brazil AnVisa, WHO Geneva, TGA, MCC, MHRA, ISO and 6 Sigma.
Led design and commissioning of green field, 420 M (USD) new production facility complying USFDA and MHRA norms. This involved challenging discussions and negotiations with city personnel, local FDA, building architects, consultants, engineering teams, pharmaceutical machinery vendors, recruiters and staffing experts.
Led implementation of quality management tools viz. TQM, Kaizen, ISO 9002 and 14000, Six sigma and QbD.
ISO and lean 6 sigma practices introduced by me increased operating efficiencies and improved tech transfer, service levels and product change over times on the production floor, resulting in net savings of 17- 22 % and increasing productivity by 200 %.
Led product due diligence, third party facility audits as well as advising ‘products of future’ for new business portfolios and approving alternate manufacturing sites.
Management :
Launched more than 1000 formulations currently being sold in over 65 countries.
Re-developed carton (package) design to permit dual orientation and save time up to 20 %, during manual packaging operations.
Supervised maintenance department for better “operational reliability”, diagnose failures, reduce breakdowns and effective spare part management.
Created records of excellence in safety/ EHS implementation in R&D and Clinical manufacturing divisions by “ Zero tolerance to accidents “.
Created risk- assessment and trouble shooting protocols for existing products to improve service levels by 15 %.
Risk assessment techniques introduced during technology transfer and trouble- shooting achieved a cost savings of 65 %.
Supervised implementation of ERP and document management systems.
Created site master files, batch records, release and stability specifications, calibrations, employee health and training, OOS investigations SOPs etc.
Designed corrective actions/ preventive actions (CAPA) effectiveness program. Oversaw review and evaluation of CAPA and ensure communication of CAPA status to cross-functional departments.
Supervised validation programs for-
Api / Drug Product.
Process.
Excipients.
Packing materials.
Facility & HVAC – Media fill trials.
Equipments- Tablet , capsule machines, Packing lines (strip, blister, pouch, FFS),Tube / Vial / Bottle filling lines, sterilization tunnels, autoclaves, hot air ovens, ball mills, water systems etc.
Created low cost analytical methods for testing with accuracy and selectivity matching HPLC for batch release of Natural health products (NHP).
Operational Expertise :
Expert with facility design and quality compliance for a variety of dosage forms including tablets, capsules, pellets, MUPS, syrups, injections, powders, ointments, creams, gels, medicated gauzes/ bandages, eye drops etc.
Expert with facility design and compliance measures for more than 21 disease areas including different antibiotics, steroids, enzymes, oncology, immune-suppressants, narcotic pain killers, anti-TB, dietary supplements, vitamins & nutritional supplements, probiotics, NHP (herbal) and biotech based products etc.
Expertise with facility designs complying to- Process layout, Line function and Fixed position layouts.
Development of Global Operations Strategy for dynamic and mid-sized life science companies.
Specialist in USFDA's Quality-by-Design (QbD) technique through Production, QA , regulatory, R&D and project divisions. Learn more on QbD...
Leadership in Operations:
Led Clinical Manufacturing department, production planning and scheduling in multi-dosage forms, multi-products, process and line function facilities. Excellent with process optimization and value stream mapping to enhance productivity and reduce wastages.
Conducted Equipment planning, Capital Budgeting and “Rationing” during facility expansions/ up gradations.
Led Supply chain management functions viz. Purchase, negotiations, contracts, vendor development, vendor approval, vendor ratings, warehouse stocking (EOQ, ABC and VED analysis) and material requirement planning (Linear programming and MRP).
Successfully led external international facility audits viz. USFDA, Health Canada, Brazil AnVisa, WHO Geneva, TGA, MCC, MHRA, ISO and 6 Sigma.
Led design and commissioning of green field, 420 M (USD) new production facility complying USFDA and MHRA norms. This involved challenging discussions and negotiations with city personnel, local FDA, building architects, consultants, engineering teams, pharmaceutical machinery vendors, recruiters and staffing experts.
Led implementation of quality management tools viz. TQM, Kaizen, ISO 9002 and 14000, Six sigma and QbD.
ISO and lean 6 sigma practices introduced by me increased operating efficiencies and improved tech transfer, service levels and product change over times on the production floor, resulting in net savings of 17- 22 % and increasing productivity by 200 %.
Led product due diligence, third party facility audits as well as advising ‘products of future’ for new business portfolios and approving alternate manufacturing sites.
Management :
Launched more than 1000 formulations currently being sold in over 65 countries.
Re-developed carton (package) design to permit dual orientation and save time up to 20 %, during manual packaging operations.
Supervised maintenance department for better “operational reliability”, diagnose failures, reduce breakdowns and effective spare part management.
Created records of excellence in safety/ EHS implementation in R&D and Clinical manufacturing divisions by “ Zero tolerance to accidents “.
Created risk- assessment and trouble shooting protocols for existing products to improve service levels by 15 %.
Risk assessment techniques introduced during technology transfer and trouble- shooting achieved a cost savings of 65 %.
Supervised implementation of ERP and document management systems.
Created site master files, batch records, release and stability specifications, calibrations, employee health and training, OOS investigations SOPs etc.
Designed corrective actions/ preventive actions (CAPA) effectiveness program. Oversaw review and evaluation of CAPA and ensure communication of CAPA status to cross-functional departments.
Supervised validation programs for-
Api / Drug Product.
Process.
Excipients.
Packing materials.
Facility & HVAC – Media fill trials.
Equipments- Tablet , capsule machines, Packing lines (strip, blister, pouch, FFS),Tube / Vial / Bottle filling lines, sterilization tunnels, autoclaves, hot air ovens, ball mills, water systems etc.
Created low cost analytical methods for testing with accuracy and selectivity matching HPLC for batch release of Natural health products (NHP).
