Aditya Sudhir Mukhedkar

• Ensured compliance with ISO 9001, ISO 14001, ISO 45001, ISO 13485, TS 16949 at 70 distribution centers.
• Developed automated tool for QMS compliance as per ISO 9001, ISO 14001, and ISO 45001, and established standardized auditing criteria scalable for 967 Facilities worldwide.
• Improved the QMS deliverable performance to 94 % FY 2022, and 2023 resulting in effective system deployment for CAPA, Documentation, and records and training management.
• Implemented EMS for NORTAM (US, MEXICO, CANADA) resulting in sustainable energy initiatives saving 5.2 M USD/ year.
• Achieved 100 % QMS Compliance for High volume sortation center leading to Global ISO 9001 certification.
• Achieved 2X Global IATA certification for distribution Hub in the US-East region (Atlanta).

• Providing engineering and technical support services to TPSI’s internal projects as well as Biopharma customers to supplement their staff in supporting projects and ongoing operations
• Leading group of 8 Engineers
• Successfully implemented cGMP, GDP, EHS, QRM, AATB, Project Management Criticality and Risk assessment, Change controls, CFR Part-11 for Big 5 Pharma companies
• Preparation of FDA CFR Part -11 FDA complaint SOPs, PMOs, WOs, SWIs, URS, Identification of Prerequisites for unit operations, using tracking tools such as Key Issue Schedule (KIS) for documenting Key Issues, associated risks, actions, discussion, and decision
• Execution of equipment Commissioning, Calibration, Qualification, and Validation of laboratory, manufacturing, and Packaging areas for 2 Pharma companies

• Spearheaded the development of product quality standards across the company’s manufacturing partners and facilities
• Proficient in ASTM, IAPMO, UL, and CSA regulations and ability to interact with regulatory agencies and peers with self-confidence, poise, and professionalism
• Expert in Supplier Quality Management, Poka-Yoke (error proofing), product testing, lean and 5s implementation, and JIT (Just in time) logistics model
• Audited 54 suppliers as per ISO 9001 & ISO 14001, EHS, PSI framework suggesting improvements as per GMP
• Swiftly addressed and resolved 36 supplier-related issues by 8-D problem solving / CAPA within 6.5 days
• Developed Rework plan, including SOP / WI for 800 toilets, and 40000 light bulbs saving USD 5M in liability costs with a focus on safe work practices, and achieved 6 Sigma process capability by simulating the entire operations
• Developed Supplier Quality procedures across the company and supply base partners, resulting in a defect rate reduction of 1.2% from 10%
• Led the development of a Scratch-resistant Bathtub saving rework costs by USD 5M/annually
• Recognized as “Best in class quality” for benchmarking product standards for 16 product categories to introduce 8 new products by validating conformance by FMEA, DOE, SPC, and APQP
• Enhanced the Supplier performance by using CAPA methodology resulting in zero defect performance
• Qualified 5000+ products as per ASTM, UL, ASME, and IAPMO product standards and listed for sale on online platforms
• Developed 22 product qualification protocols,100 % compliant with regulatory and statutory standards

• Directed all planning and evaluation of key cost operational metrics to ensure optimized production, maintenance, and quality
• Performed simulation models to generate the most profitable product mix, TPM for the maintenance shop, and TQM across 11 production lines
• Developed and tracked 15 operational KPIS resulting in a decrease in manufacturing overheads from 0.15 USD/lb
• To 0.12 USD/lb
• Developed and tracked OEE for 11 manufacturing operations leading to continuous improvement achieving an 8 % increase in productivity, a 13 % reduction in downtime, and USD 250K in savings
• Automated data reporting for FDA Audits, preventative maintenance schedule for 18 operations achieving cost savings of 185 K USD
• Achieved a 99.96% level of Inventory cycle count accuracy by implementing control procedures and tracking inventory by implementing advanced stochastic optimization models

• Diligently identified opportunities to improve processes through continuous evaluation of capacity, bottlenecks and utilizing metric/measurement data to create improvement plans
• Championed a 12% improvement in time standards by collecting cycle time data on warehouse distribution processes (Time Study)
• Secured a 20% reduction in cycle time and a 33% spike in productivity by performing time studies and documenting and revalidating the Standard operating procedures to calculate the standard time for door reversal for whirlpool refrigerators and dryers resulting in annual savings of USD 176K

• Strategically mapped operations and production to support new product development activity
• Added 5 new OEM customers to the hydraulics group increasing revenue by 2.5 M USD/ Yr
• Key Account Management for A-rated OEM with sales worth 5.2 M USD/ Yr
• Launched 23-12 cc Gear pump for Export tractor products

ABET Accredited

• 3.8 GPA

• 4.0 GPA