Varadharaj Vijayakumar
Senior Subject Matter Expert-aseptic Fill Finish Freeze Drying @WuXi Biologics
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WORK HISTORY
Senior Subject Matter Expert-aseptic Fill Finish Freeze Drying @WuXi Biologics
Cologne, DE
EDUCATION
The Tamilnadu Dr M.G.R Medical University
Bachelor of Pharmacy - B.Pharm, Pharmacy, Pharmaceutical Sciences, and Administration, First
Anna University Chennai
Masters, Pharmaceutical Management
ABOUT VARADHARAJ VIJAYAKUMAR
Experience: 14 years of experience in Sterile Operations such as Biologics, Pharma, oncology/Isolators/Lyophillization techniques with Pfizer, Biocon, Emcure, Dr Reddy Laboratories.( Experienced from Production function to regulatory audit success )(Detailed Summary about products handled will be provided on request) Career Overview: Experienced pharmaceutical and biopharmaceutical professional with 14 years’ hands-on experience in sterile pharma and Biologics injectable with aseptic operations, qualification and validation activities related to cleanrooms, equipment, and other utilities, coupled with quality management system to cover important elements like documentation requirements, corrective and preventive actions (CAPA), deviations, out-of-specifications, change control etc. I was leading entire sterile operations with three major lines, No failures and achieved great production outputs without any quality issues Key team member to establish two green field projects, make it operational and successfully obtain regulatory approvals. Profile Sound knowledge in Isolator technology, Lyophillizers, Dry powder lines, Nasal spray technology and over all Filling Lines – PFS, Cartridges, Vials, including qualification and validation document. Handled dosage forms like, Unit dosage Nasal spray, Cartridges, Vials, and Pre- filled syringes, Lyophilized Vials, Blow fill seal technology and hands on experience in Isolator technology with bio decontamination methods. Experience in routine operations, qualification and validation, quality management systems, and equipment troubleshooting to include the preparation and review of Validation Master Plan (VMP), Standard Operating procedures (SOP), QMS requirements like change control, incident reporting, failure investigation, audit compliance, qualification and validation protocols and reports (supporting utilities, equipment), aseptic media fill studies, risk assessment, User requirement specification etc.
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