Experience

DD Enterprises

• India
• Biotechnology Research
• 100 - 200 Employee

• CSV Engineer

  • May 2023 - Present

  Prepare and execute validation documents for computer systems, ensuring compliance with industry guidelines and regulations. Adhere to Good Manufacturing Practices and develop Validation Master Plans for maintaining compliance. Validate equipment and IT infrastructure used in pharmaceutical and bioprocess manufacturing. Collaborate with client IT to qualify infrastructure components and implement automation solutions. Maintain a customer-focused approach and align work with organizational objectives. Perform computer system validation in the pharmaceutical industry, ensuring regulatory compliance. Prepare and review various validation documents such as GxPA, URS, EAC, VPP, FRS, FRA, DCS, QRM, VP, Traceability Matrix (TM)etc. Design test cases and execute IQ, OQ, and PQ. Review CSV documents prepared by team members. Ensure compliance with GAMP, 21 CFR Part 11, and EU Annex 11 guidelines. Coordinate with vendors to fulfill user requirements. Show less



Maktech India system service (LLP)

• Aurangabad, Maharashtra, India

• Validation Engineer

  • Mar 2021 - May 2023

  Worked for company: Lupin Limited Aurangabad, Lupin Biotech Pune and Lupin Limited Goa. Worked for company: Lupin Limited Aurangabad, Lupin Biotech Pune and Lupin Limited Goa.



CDET Explosive Industries Private Limited

• Wardha, Maharashtra, India

• Trainee Instrumentation Engineer

  • Feb 2020 - Feb 2021

  Plant Maintenance of HX Division Calibration, Measurement & Testing. Rectification of Electronic Device Monitoring on SCADA and PLC Panel Documentation and Paper Work ERP Application used. Plant Maintenance of HX Division Calibration, Measurement & Testing. Rectification of Electronic Device Monitoring on SCADA and PLC Panel Documentation and Paper Work ERP Application used.