Geevarghese Manaloor Puthenparampil

QC Manager with an M.S. in Analytical Chemistry. Experienced in GMP raw materials labs and clinical biotech manufacturing. Seeking an Associate Director role.

• Introduced continuous improvements to raw material testing procedures while working at Teva, which resulted in significant cost savings (saved 50% testing budget) in testing expenses.
• Collaborated with Research and Development team to begin in-house testing and validation.
• Successfully implemented in-house testing for USP and EP raw materials at Teva and Cellphire, which resulted in cost savings.
• Prioritized and cleared all pending testing, sampling, and quality control release backlogs at Teva. This resulted in the urgent availability of materials for manufacturing use. In total, 70 backlog materials were released in addition to routine projects, bringing the department up to date.
• New cGMP lab setup completed for Phase III activities with IQ, OQ, and PQ at Cellphire.
• Awarded best employee of the year 2017-2018 for managing QC testing and material releases to meet urgent business needs at Jubilant Cadista.

• Worked as a QC executive in NeoPharma ,UAE (January 2006-September 2010), tested raw materials, tablets and capsules by HPLC.
• Worked as a QC executive in Aurobindo Pharma, India, July 2004-June 2005, tested tablets and capsules by HPLC.

• Received the Chairman's Award at Jubilant Cadista for best employee and significant contribution due to managing releases of raw materials and performing timely testing to meet urgent business requirements.
• Received a spot-on Award in Jubilant for successful analytical method transfer from R&D to QC within a short time.
• Received Spot on Award in Jubilant for demonstrating multiple tablet dissolution techniques for Telmisartan Tablets from R&D to QC.
• Saved Raw Materials testing costs by implementing continuous improvements and in-house testing strategy in Teva Pharmaceuticals.
• Cellphire's new cGMP QC lab was successfully relocated for phase III with all instrument IQ, OQ, and PQ completed in a short time, without impacting routine testing and release for the manufacturing schedule.

Leadership and Mentoring, Flexibility and Collaboration, Quality Focus, Project Management and Implementation, Project Management, Communication and Interpersonal Skills, Experience with Cell, Regulatory Knowledge, chromatography HPLC, UPLC, GC, GCMS, Dissolution, UV Visible Spectroscopy, KF-Titrator, Auto Titrator, IR, TOC, DSC, Particle Size, protein concentration, Titer, Flow Cytometer, plate reader, Aggregometer, LIMS (Laboratory Information Management System) software., ERP, Blue Mountain, IQ/OQ/PQ, calibrations, computer system validations (CSV), Compliance-Wire, Master Control, Studium, SharePoint, SAP, data integrity, USP, BP, EP Monograph, Track Wise, Veeva,Tulip,GLP, Empower 3, ICH, CMC, Mass Hunter Software, Labx Software, cGMP, CAPA, change controls, deviations, investigations, OOS, internal audit and FDA audit, validation, data review, tech transfer, Drug substances, Drug products, Excipients, In-process samples, Finished products, and Stability samples, research and development, troubleshooting.