Asutosh Shah
Associate Director, Quality Systems & Compliance @Hikma Pharmaceuticals
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WORK HISTORY
Associate Director, Quality Systems & Compliance @Hikma Pharmaceuticals
Cherry Hill, NJ, US
Manage and Oversee the Quality Systems and Compliance functions such as regulatory inspections, Client audits, Internal audits, Customer Complaints, Annual Product Reviews, Site CAPA system, FAR, Recall, Quality Agreements and supplier audit program. Responsible for managing operations of Training and Documentation Group. Plant liaison for compliance related initiatives with Corporate Compliance Group. Conduct monthly management review of plant quality metrics with site and corporate management to ensure compliance. Final QA authority for release of the quality products for Third Party Manufacturer (TPM)
EDUCATION
Gujarat University
BS, Microbiology
SKILLS
ABOUT ASUTOSH SHAH
Associate Director of Quality Systems and Compliance with over twenty-six years of extensive experience in QA Compliance, Quality Assurance and Manufacturing of Pharmaceutical products and Vaccines. Areas of expertise include regulatory inspections, audits, customer complaints, APRs, FAR, recall, documentation, training, aseptic processing, FDA and EU regulations, quality systems such as supplier quality, in process monitoring, batch record issuance and release, cGMP documentation, manufacturing investigations, management review and change controls. Recognized for increasing productivity with a commitment to compliance and teamwork. Hands on experience with applications like SAP, SmartSolve, LIMS, POMS, JD Edwards, Trackwise, PRMS, ASI, ISOtrain. Experience in startup of manufacturing facility, continuous improvement, product launch, process and equipment validation, CAPA system, auditing, cost control, lean culture and Kanban. Result oriented, team player, highly motivated, and energetic. Strong leader with motivational management style and reputation for building and retaining highly motivated teams.
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