Deepesh Rajput
Clonakilty,Ireland
Summary
Highly motivated professional with a strong commitment to deadline adherence and effective time management. Demonstrates a positive attitude and willingness to learn, coupled with exceptional department management skills. Seeking opportunities to leverage these competencies in a dynamic work environment.
Overview
7
7
years of professional experience
Work history
CSV Executive
Symbiotec Pharma
Indore , India
02.2024 - 03.2025
- To prepare CSV document (Initial Risk Assessment , Validation Plan, FS , DS, IQ ,OQ, PQ , RTM, Business Continuity Plan and Project Closure Report) and Execute the activity.
- To Prepare computer system validation documentation in accordance with site procedures ,GMP and GAMP5 guidelines
- Qualification of QC CDS software validation like : Empower, Chromeleon.
- QC Non CDS Software like : Stability Chamber Software- Allysoft, Malvern Software , FTIR.
- Qualification of DCS (DeltaV) Software.
- To perform QMS Activity (Change Control, Deviation)
- To participate in SAP S/4HANA 2022 CSV execution of the MM module.
- To prepare the validation monthly plan activity.
- Maintain and upgrade IT site inventory.
- Collaborate with software vendors to ensure that system validation documentation is complete and accurate.
- Perform periodic reviews of validated systems to ensure continued compliance.
- Author, review and approve validation documentation, including validation plans, reports, and risk assessments
- Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11
- Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.
CSV Executive
Brisk Technovision Pvt. Ltd (Client : Ipca Pharma)
Indore , India
01.2023 - 02.2024
- To Prepare CSV document (Initial Risk Assessment, Validation Plan, FS, DS, IQ, OQ, PQ and RTM activity)
- To Prepare computer system validation documentation in accordance with site procedures ,GMP and GAMP5 guidelines.
- Qualification of QMS Software validation Trackwise, Access Management System.
- Qualification of QC software validation like : Empower, Chromeleon, One Lab Solution, Enviro Stability Software.
- Qualification of SCADA Software (Factory Talk View Site Edition)
- Qualification of Manufacturing Equipment Software.
- Prepare and Execution GAP Assessment of GxP Computerized System.
- Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
- To perform QMS, change control, and deviation activity.
- To Perform Documentation in EDMS (Document Creation, Document workflow and Document released)
- Perform periodic reviews of validated systems to ensure continued compliance.
- Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11.
- Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.
CSV Consultant
Persolkelly (Client : Ipca Pharma)
Indore , India
12.2022 - 12.2023
- Client Relations, Project planning and Delivery
- Generate CSV Validation plan detailing the scope and work of intent.
- To Prepare CSV document (Initial Risk Assessment, Validation Plan, FS, DS, IQ, OQ, PQ and RTM activity)
- Qualification EDMS Software (Validation Modules and SOP Modules)
- Qualification of QC software validation like : Chromeleon, One Lab Solution, Enviro Stability Software.
- Qualification of Manufacturing Equipment Software.
- Prepare and Execution GAP Assessment of GxP Computerized System.
- Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
- To perform QMS, change control, and deviation activity.
- To Perform Documentation in EDMS (Document Creation, Document workflow and Document released)
- Perform periodic reviews of validated systems to ensure continued compliance.
- Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11.
- Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.
QA Validation Officer
Lupin Pharma
Indore, India
06.2018 - 11.2021
- To prepare / review / Coordinate the equipment/ system/ facility qualification (OSD and Ophthalmic Facility) documents and Periodic verification related activity.
- Prepare / review/ Coordinate qualification / periodic verification of HVAC System and review Schedule for timely completion of activity.
- To prepare the Temperature control protocol and executed.
- Review / Coordination qualification/ Periodic verification of Compressed air system.
- To perform QMS activities, change control and deviation.
- To prepare the validation plan and perform execution activity according to the validation plan
- To Participate in and support audit activities
Education
Bachelor of Pharmacy - Pharma
Smriti College of Pharmaceutical Education ( RGPV )
2014 - 2018
Skills
- Self-motivation
- Deadline adherence
- Positive attitude and willingness to learn
- Time management
- Department management
Timeline
CSV Executive
Symbiotec Pharma
02.2024 - 03.2025
CSV Executive
Brisk Technovision Pvt. Ltd (Client : Ipca Pharma)
01.2023 - 02.2024
CSV Consultant
Persolkelly (Client : Ipca Pharma)
12.2022 - 12.2023
QA Validation Officer
Lupin Pharma
06.2018 - 11.2021
Bachelor of Pharmacy - Pharma
Smriti College of Pharmaceutical Education ( RGPV )
2014 - 2018
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