Anand Thota

Quality Assurance Manager and Head of the Laboratory @Vivariant Laboratories

Design and implement comprehensive quality management system complaint with GMP and ISO standards- Establish, develop and implement Document Control in compliance as per current GMP and ISO standards- Develop and implement Plan Deviation, Non-conformance, OOS investigation and CAPA implementation program- Establish, manage, and execute internal audits along with necessary action implementation- Handling customers for technical, quality, and business-related information for multiple industry regulatory guidance such as FDA, Health Canada and ISO- Participation in business development with client interaction and cost management- Review and Approve quality control processes and QA activities- Review and approve validation protocols, reports, SOP’s, and other quality documentation- Develop and implement calibration, and preventive maintenance program for various equipment- Establish and manage training program for new and existing employees- Hire and manage all department managers and quality department employees- Assist in procurement of equipment to set up analytical chemistry department for multiple testing- Review and Approval of method validation for various analytical testing procedures- Review and Approve raw data for various analysis using ICPMS, HPLC-UV, LC-MSMS, GC-FID and MS etc, ID test and quantification test- Coordinate, manage and lead all external client and regulatory audits- Vendor qualification and management for procurement of various equipment and materials- Create and implement Management review program- Establish Performance Evaluation program and Personnel development program for employees.