Dec 2021 – Mar 2023 · 1 yr 3 mos · Chennai, Tamil Nadu, India

• Review of all deliverables such as Validation Plan, Validation Report, Test strategy, IQ, OQ and PQ specifications.
• Review of Change Request, Deviation, CAPA and Incident Management as part of Operational Quality Manager.
• Track Periodic review reports as part of Validation Plan and perform all controls (Incident, Audit trail, User Access Management, Backup and restore etc.,) required as part of Periodic review.
• Perform mock audits of all GxP applications as part of Inspection readiness.
• Review of Project deliverables during Transition from Project to Operations.

May 2019 – Nov 2021 · 2 yrs 6 mos · Bengaluru Area, India

• Review and/or assist in developing validation strategies and associated documentation against the requirements of Biocon’s CSV Policy and procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved.
• Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects.
• Development of Validation Plan, Requirements Traceability Matrix, Risk Assessment, IQ/OQ/PQ Study Protocols, Validation Summary Report, Change control, SOPs.
• Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review
• Review & provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP’s and regulatory requirements.

Sep 2017 – Apr 2019 · 1 yr 7 mos · Chennai Area, India

• Carrying out Calibration of the Test instruments Pertaining to Thermal, Electro-Technical, Mechanical (Pressure, Torque and Mass) and Optical and preparation of Calibration reports
• Upholding laboratory standards and performing regular Intermediate checks, Inter Laboratory Comparison (ILC) & carrying out Periodic Maintenance of standard instruments
• Preparation of Uncertainty calculations for all types of instruments

Feb 2017 – Aug 2017 · 6 mos · Puducherry, Puducherry, India

• Assisting the Senior Executive in preparation of Master List, SOP and Calibration schedule for all Field Instruments
• Carried out Calibration of Temperature, Flow, Mass, Level, Pressure and Humidity measuring instruments and maintaining Calibration records

Aug 2015 – Feb 2017 · 1 yr 6 mos · Puducherry Area, India

• Performing both onsite and in house calibration of instruments pertaining to Thermal, Mechanical and Electro – Technical field as per standard calibration procedures in compliance with ISO 17025 and preparation of Calibration reports
• Responsible for performing regular Intermediate checks and Inter Laboratory Comparison for master instruments
• Led the Thermal Lab in NABL Audit