Suraj Kanhekar
Bhandara
Summary
Top continue my career with an organization that will utilize my Engineering & Leadership skills to benefit mutual growth and success. Eager to learn new technologies and Methodologies. Always willing to Innovate the new things which can improve the existing technology. good progress in a career by using my technical and non-technical knowledge for developing industries.
Resourceful CSV Validation Engineer well-versed in Preparing Validation Documents as per systems categorization and also prepared IQ, OQ and PQ test scripts for testing of system. Experience of various software system in various companies.
History of meeting company needs with consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
9
9
years of professional experience
Work History
CSV Consultant
Maktech India System Services Pvt. Ltd. Aurangabad
Pune
06.2022 - Current
- Investigated root causes of any discrepancies found during validation testing.
- Developed protocols for validating Computerized Software system against internal and industry standards.
- Created test scripts and executed tests according to the validation plan.
- Provided continuous process improvement and preventive and corrective actions to facilitate operational efficiency.
- Performed risk assessment activities for computer systems.
- Validated the Biometric Software for Quality Control Department at Lupin Pharma ltd Aurangabad.
- Also working on Bottle Serialization System for Packing line at Lupin pharma Ltd. nagpur.
- At Serum Institute of india Pvt. Ltd Pune Validated the System Used for Manufacturing Like BioZeen Vessel, BioTree Vessel, Fedegiri Autoclave etc.
CSV/PLC Validation Engineer
Integral Solutions Pvt. Ltd. Indore
Indore
09.2021 - 06.2022
- Excellent Knowledge and experience in Good documentation Practices.
- Reviewed and Validated Computer System in Compliance with 21 CFR part 11 and GxP FDA Regulations.
- Prepared and Review the Validation Protocols IQ / OQ / PQ , FRS, VP, VPP, VSR, Risk Assessment, Periodic Review Report etc.
- Experience in Developing and reviewing URS, FRS.
- Prepared traceability matrices to ensure traceability of system components.
- Verified that all systems were functioning according to design parameters through testing and inspection.
Calibration Engineer
QATech (A Division of GMP Technical Solutions Pvt. Ltd.)
Mumbai
03.2015 - 08.2021
BioZeenliance with applicable regulations such as FDA 21 CFR Part 11 when performing calibrations.
Experience of calibrating instruments like Pressure Gauge, Temperature Gauge, Temperature Sensor, Safety Valves, Deep Freezer, Incubators, Thermometers, Ovens, Centrifuges, Timers, Level Switch, Flow Meter, Rota Meter, Temperature Scanner, Temperature Controller, BMS system instruments, Transmitters, Safety Valves, Control Valves etc.
Provided the Service as calibration Engineer at PharmaPharma Ltd. Nagpur OSD And injectable Plant.
Handled the Calibration Sites in companies like Reliance Rabale, Serum Institute of India Pvt. Ltd. Pune, Lupin Pune,PharmaPharma Pimpri, GalPharmaPharma Rabale, Athena Ambernath, Inventia Ambernath, USV Ltd. Govandi, Inventia Thane, Alkem Laboratories Ltd Ankleshwar, Alkem Laboratories Ltd. Mandva, Wockhardt Ltd. Ankleshwar, FerPharmaPharma Dahej etc.
Education
Bachelor of Engineering - Mechanical Engineering
P.I.E.T Nagpur
Nagpur06-2015
High School Diploma -
Sarvajanik Vidyamandir Pen
Pen, Raigad03-2011
SSC - Art
Manoher Vidyalaya Gurdha
Gurdha, Lakhani03-2009
Skills
- Process Validation
- Testing Management
- Report Writing
- Test Case Development
- Validation Testing
- Leadership
- Excellent Communication
Accomplishments
- Paper Presentation in National Level conference on Advances in Engineering, Technology & Applied Sciences NCOAT-NIRMITY 2015 on Fabrication of solar scooter.
- Participated in One day seminar on POWER PLANT FAMILIARISATION, organized by National Power Trainning Institute(Western Region) Nagpur.
- Participated in the event LATHE BECKON of ANTAHEEN 14 and exhibited admirable competence thereby securing 2nd position.
Affiliations
- A study and Research on THE MANUFACTURING AN D FABRICATION OF SOLAR E-SCOOTER.
- An experimental Investigation of Performance Characteristics of A SOLAR E-SCOOTER.
- Completed the Mini-Project on AUTOMATIC HACKSHOW.
Languages
Marathi
First Language
English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Timeline
CSV Consultant
Maktech India System Services Pvt. Ltd. Aurangabad
06.2022 - Current
CSV/PLC Validation Engineer
Integral Solutions Pvt. Ltd. Indore
09.2021 - 06.2022
Calibration Engineer
QATech (A Division of GMP Technical Solutions Pvt. Ltd.)
03.2015 - 08.2021
Bachelor of Engineering - Mechanical Engineering
P.I.E.T Nagpur
High School Diploma -
Sarvajanik Vidyamandir Pen
SSC - Art
Manoher Vidyalaya Gurdha
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