Please go through the below job description,and please let me know your
*TITLE: CSV Consultant (Computer System Validation)*
*DURATION: 6+ Month*
- Total IT experience 9+ Years
- Knowledge of industry standards & regulations
- Ability to work independently & handle the entire project
*Position Skills Requirements:*
- 8+ years of experience in CSV Implementation
- Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11
on electronic records, electronic signatures etc.
- Define Risk based strategies for validation of computerized systems
and author/review end-to-end Computerized Systems Validation documentation
in accordance with Computerized Systems Validation Master Plan
- Perform system risk assessments, systems gap analysis, review and
approve action plans to ensure compliance during and after the system
- Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
- Help, guide and direct the project manager during the system
implementation and validation process, and ensure compliance with corporate
policies and procedures.
- Provide training related to computerized systems validation, quality
and compliance to users and appropriate personnel
- Experience in Internal Audit, External Audit. Face regulatory,
customer, IT Quality System related inspections for all computerized systems
- Responsible for review & verification of Corrective Action Plan for
- Perform periodic review/monitoring of computer systems implemented
- Proven experience in developing Master Validation Plan, validation
scripts, Validation reports, all documentations required during CSV
- Bachelor Degree in Engineering, Computer Science OR equivalent through
experience. Advanced course work in technical systems plus continued
education in technical disciplines is preferred
- Language proficiencies
- English spoken and written
*ll IT-SCIENT ll Phone: 510-516-7859 ll Official: rajat.
*ll Email: rajat.itsci...@gmail.com
<surajkumar.itsci...@gmail.com> ll Web: www.itscient.com
You received this message because you are subscribed to the Google Groups
To unsubscribe from this group and stop receiving emails from it, send an email
To post to this group, send email to email@example.com.
Visit this group at https://groups.google.com/group/reqsresumes.
For more options, visit https://groups.google.com/d/optout.