Devendra Vijay Email & Phone Number

Mumbai Area, India

Directed 3 manufacturing locations for regulated and India market. Each site has multiple manufacturing blocks, catering to US, EU, EM & India Market. Dedicated blocks for General products, Penicillin, Cephalosporins, and Immuno-suppressant for manufacturing of multiple dosage forms i.e. Tablets, Capsules, Oral suspensions, dry powder injectable, Liquid injectables in vials, ampoules & lyophilized bulk injectables. Approx. 5500 people employed across all blocks at three locations. Highlights: Steered successive 9 regulatory inspections at Baddi & Daman locations (USFDA, TGA &Germany) Four fold increase in productivity within a span of four years. Securedapprox. 40% productivity increase in 2017-18 through Mission -17Excellence Program, slashed cost per pill from 59 to 42 paisa including 4% in OPEX budget and 20% in energy consumption Drove manufacturing excellence program PACE in 2018-19 with the support of McKinsey & Co. and achieved further productivity improvement by 35% which resulted in reduction of cost to 32 paisa per pill Distinctively implemented IoT solution for online OEE monitoring at one site and rolling down to other sites Introduced high-end production machines, integrated granulation lines, Installation of HMI to upgrade PLCs and replacement of old PLCs to comply 21 CFR requirements Built a team of staff and techniciansto operateHMI & SCADA equipped 21 CFR compliant machines Credit of reducing granulation cycle time of one product from 28 hours to 8 hours and another product from 48 hours to 22 hours Increased compression machines speed from average 25 to 40 RPM Pivotal role in installingdesiccant based dehumidifiers in FBD for reduction of drying time Reduced time of Type A cleaning from average 4.5 hrs to 2.5 hrs and Type B cleaning time from 16 hours to 8 hours Pivotal in implementingskip test for blend & RM for half a dozen products Steered in implementing track and Trace system

Hyderbad

Managed Beta-lactam formulation plant, a medium size unit employing approx. 1000 people, manufacturing penicillin’s range of products in different dosage forms i.e. Dry powder Injectables, Lyophilized vials, Tablets, Capsules, and PFOS. The site is approved by leading regulatory agencies USFDA, MHRA, FIMEA, TGA, ANVISA, TFDA, and other emerging markets. Highlights: Steered 8 successful regulatory audits during 4 years tenure Enhanced microbiological contamination control by improving aseptic practices, pressure differential controls between the aseptic areas, change in gown washing procedure that brought excursions much below guidance values Ensured increase in productivity by increasing batch sizes of sterile APIs Contributed in reduction of Lyophilization cycle time by increasing vacuum capacity including two existing pumps third pump installed Improved coating process of a sensitive tablets by achieving less than 1% Rh in supply air by modifying air treatment system and brought down batch rejection rate from 10% to almost nil Rectified black particle problem in dry syrup filling & packing and eliminated batch rejections by re-establishing induction sealing parameters 50% increase in productivity in wet granulation by optimizing processes, process control and cycle time monitoring primarily by working on people. Approx. 10% reduction in energy consumption by efficient production planning, manufacturing cycle time reduction, increasing batch sizes and machine speed

Baddi

Site In-Charge, Operations head. Production of sterile & non sterile formulations.

Baddi

Plant In-Charge, Operations head. Production of Tablets , Capsules & Liquid orals.

Master Of Pharmacy, Pharmaceutical Science ( Pharmaceutics), A

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences