Anchanapally Harikrishna

Results-driven senior executive with a demonstrated history of spearheading strategic growth and operational excellence in the Pharmaceuticals Industry Quality Control. Boasting 13.5 years of experience, this innovative professional has honed expertise in e-Caliber LIMS Master creation and management, along with conducting comprehensive investigations into OOS, OOAL, Deviations, Laboratory Incidents, CAPA's, and Change controls. Proficient in preparing SOP's and conducting IQ, OQ, and PQ of new equipment. Offers extensive experience in QC Instrumentation and troubleshooting.

• Handling of OOS, OOT, LIR's, change controls and Deviations and its criticalities Implementation of CAPA's. Preparation of SOP's.
• Maintaining GLP Activities in the Lab, Qualification of Working Standards, Calibrations of Instruments.
• Maintaining AMC, PM and External calibration schedules and execution as per schedule. Caliber LIMS Master, Creation of LIMS masters and execution.
• Ability to demonstrate strong skills in leadership, decision making, Risk management, continuous improvement and problem solving
• Knowledge in ICH guidelines and pharmacopeias. Audit support and investigations. Computer System Validation, CAPA, GxP Standards
• Operating and trouble shooting skills on all analytical equipment's.
• Review of Audit Trails in Empower and standalone software's.
• Working with the cross-functional teams in the development and execution of validation activities associated with new equipment, processes, or system upgrades.
• Subject matter expert and provide training on quality events investigation and implementation of effective CAPAs.
• Identify gaps in systems, develop and cross-functionally drive, feasible plans for correction, ensuring an effective balance of compliance and efficiency
• Ensure all validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria are complete and deviations are documented.
• Collaborate with multiple internal disciplines and external product, process, and program teams to represent compliance requirements within the QMS.

• USFDA
• MHRA
• WHO
• PMDA
• Customer Audits

• Father's Name: Shri. Late A.Gopal
• Mother's Name: Smt. A.Shanthamma
• Date of Birth: 04/27/87
• Marital Status: Married

• 2Nd winner in Employee of the Month in 2020 (Month January)