Ajay Kumar
Gurgaon
Summary
Interested to work at a challenging position in a company where experience, education, training & strong professional growth can be achieved with full dedication with my skills and functional knowledge. To lead and successfully implement a Project as CSV person in company. + Longterm (In the next 3-5 years). To become a Project Manager or Lead for company and to run at least 5 big successful IT Project campaigns for the company.
Overview
14
14
years of professional experience
2
2
Certifications
Work History
Senior Executive
Sun Pharmaceuticals Industry Ltd.
06.2017 - Current
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Proven ability to learn quickly and adapt to new situations.
- Skilled at working independently and collaboratively in a team environment.
- Demonstrated exceptional problem-solving skills when faced with complex issues related to computer system validation efforts.
- Increased efficiency in documentation management by creating well-organized repositories for all CSV-related materials.
- Developed comprehensive test plans to ensure successful system implementation and user acceptance.
- Collaborated closely with clients to develop customized training materials tailored to their specific needs and expectations for CSV projects.
- Actively participated in project review meetings, providing valuable input on progress updates and potential roadblocks encountered during the course of the work.
- Reduced validation errors by conducting thorough risk assessments and gap analyses.
- Delivered high-quality deliverables consistently while adhering to strict deadlines, resulting in increased client satisfaction levels.
- Streamlined project timelines by effectively managing CSV tasks and resources.
- Improved compliance with industry regulations through diligent adherence to CSV guidelines and best practices.
- Produced and maintained technical documentation for project reference.
- Reduced instances of non-compliance through proactive monitoring and timely corrective action plans.
- Streamlined internal processes by implementing effective IT controls, policies, and procedures.
- Established effective incident response procedures to minimize impact from potential breaches or non-compliant situations.
- Improved IT compliance by conducting regular audits and monitoring system performance.
- Identified potential risks by conducting thorough analyses of existing IT systems and infrastructure.
- Developed improvement and corrective action plans to bring operations in line with requirements.
- Addressed technical issues and guided end users through resolution.
- Enhanced application performance by identifying and resolving technical issues in a timely manner.
- Assisted with the integration of third-party applications into existing systems, enhancing overall functionality.
- Conducted regular audits of applications for security vulnerabilities, addressing any findings promptly.
- Collaborated with cross-functional teams to identify areas for improvement and implement solutions.
IT support Enginner
RANDSTAD INDIA PVT, LTD
11.2017 - 07.2018
- Nov 2017 to July 2018. Project – Sunpharma (Vadodara, Gujarat)
Sr. Officer
SUN PHARMACEUTICAL INDUSTRIES LIMITED
11.2017 - 07.2018
- Nov 2017 to July 2018. Project – Sunpharma (Halol, Gujarat)
- I have faced following external regulatory Audits as an SME for Lab Applications Administration andValidation: USFDA, TGA, MHRA, CDSCO, ANVISA, MHLW, WHO.
- Also I have faced so many domestic auditors as an SME for Lab Applications Administration andvalidation.
- All of my work experiences have involved working within a team-based culture. This involvedplanning, organisation, coordination and commitment.
IT support Enginner
HCL INFO SYSTEM LTD
01.2012 - 10.2017
- Jan 2012 to Oct 2017. Project – Sunpharma (Gurgaon)
Education
MBA in IS - Information system, IT (Computer System Management)
SIKKIM MANIPAL UNIVERSITY
06.2011
Bachelor in ARTS (B.A) - undefined
MDU UNIVERSITY
Rohtak06.2009
Skills
Computerized System Validation
Project Implementation & Management
Lab Application Administration
Audit Support as an SME
Lab Application Troubleshooting
QMS Activities(Investigations, CAPA,CCR)
Backup Administration
Application Support
Certification
CCNA (Cisco Certified Network Associate).
Interests
To be a part of Project Implementation Team for critical and overseas projects, To work as Quality Reviewer in IT Department
Honors & Awards
HCL INFO SYSTEM LTD 2014 Appreciation certificate for Best Engineer.
Activities
ACTIVITIES THAT I HAVE PERFORMED THROUGHOUT MY CAREER 2012 - NOW Computerized System Validation for Lab Applications Systems. I have gained very good experience by performing Computerized System Validation activities forbelow application software used for Quality Control Laboratories as site CSV Lead person: Empower 3 SR2, Chromelon 7.2, LabSolutions 6.72, LabX 2014 & 2018, ICDAS 2.1, Thermocilent,Classagent, UV Winlab, VI Connect, LIMS, TOC Control, DiversiLab, Analyst 1.6.3(LCMS), Jasco Polarimeters, Erweka Hardness Tester, Rheocal T, Rheo3000, Mastersizer2000 & 3000, Syngistix ICP, Vitek 2, hemWizard+, ImageCompare,LBPC, Zetasizer 7.12., Laboratory Standard Management Software (LSMS).
Additional Information
I also have decent knowledge about GAMP5, EU Annex 11, ICH Q9 and 21 CFR Part 11Requirements.
Timeline
IT support Enginner
RANDSTAD INDIA PVT, LTD
11.2017 - 07.2018
Sr. Officer
SUN PHARMACEUTICAL INDUSTRIES LIMITED
11.2017 - 07.2018
Senior Executive
Sun Pharmaceuticals Industry Ltd.
06.2017 - Current
IT support Enginner
HCL INFO SYSTEM LTD
01.2012 - 10.2017
MBA in IS - Information system, IT (Computer System Management)
SIKKIM MANIPAL UNIVERSITY
Bachelor in ARTS (B.A) - undefined
MDU UNIVERSITY