Vignesh Prakasam

About Vignesh Prakasam

Manufacturing and Quality Professional, with progressive experience, in Pharmaceutical and Cosmetics Manufacturing, Filling and Packaging. Experienced in change management, quality systems remediation, and shop floor support services. Skilled in root cause analysis (RCA) tools, coaching and developing personnel, and continuous improvement.

Experience

1. Manager, Quality Assurance and Quality Systems

   kdc/one, Columbus

   May 2024 — Present

   Responsible for executing Quality Operations and Quality Systems across 2 plants (2 manufacturing sites with integrated warehouses and 1 off-site warehouse)Lead multiple Quality Teams responsible for 1. incoming receipts, inspection, testing and release of packaging components2. In-process quality checks on the filling and packaging lines, assembly lines3. Auditing the batch records (compounding, filling and packaging), prepare COAs for finished product releases4. SAP Master Data Management5. Non-conformances, Change Controls and Internal AuditsIdentify, Investigate, and document the non-conformance, root cause analysis and corrective action design and implementation, effectiveness checksSME and Key User of SAP master data management of Materials Management, Inventory Transactions, and PickingMaintains the audit-ready status of the sites for ISO22716 and FDA 21CFR Part 210/211 complianceProvide data to aid the preparation of APR (APQR), and function as approver of the APQROwn and enable the authoring, preparation, execution and approval of the Equipment and process validations, filling and assembly instructionsLead the investigation of customer complaints in identification of the root cause analysis and preventing the recurrence of the non-conformancesSME of packaging component analysis for critical quality attributesCoach, train and develop the personnel to document and investigate the Non-Conformances, Analytical and Microbiological OOS.Lead various CI initiatives including but not limited to FIFO picking, digitizations of the change control management and documentation controls, significant reduction of quality issues, and customer quality call outs.

Education

• University of Windsor

  Master of Engineering (M.Eng.), Environmental Engineering

  2015 — 2017

• Shanmugha Arts, Science, Technology and Research Academy

  Master of Technology (M.Tech.) (US and Canada Equivalent to Bachelor's and Master's by WES), Industrial Biotechnology

Skills

• Environmental Engineering
• Design of Experiments
• Bioprocessing
• Microsoft Excel
• Downstream Processing
• Microsoft Powerpoint
• Aas
• Fermentation
• Microsoft Outlook
• Chemistry
• Gc
• Teaching
• Research
• Good Laboratory Practice (Glp)
• Productization
• Hplc
• Microsoft Access
• Minitab
• Microsoft Word
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Thin-Layer Chromatography (Tlc)
• Uv-Vis-Nir
• Uv/Vis Spectroscopy
• Dissolution
• Chromatography
• Microsoft Office
• Biotechnology
• Research and Development (R&D)
• R
• Ion Exchange
• Chemcad
• Autocad Plant 3d
• Ftir
• Sds-Page
• Laboratory Skills
• Pcr
• Chemical Engineering
• Gdp
• Microbiology