Computer System Compliance Consultant Resume

SUMMARY

Experienced in CSV and Life science Compliance.
Successfully executed and completed CSV - Audit, training, Projects, Gap Assessments, Gap remedies and International Audit support in 40+ well non life science companies.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Computer System Compliance Consultant

Confidential

Responsibilities:

Working as a fulltime computer system compliance and CSV consultant independently.
Providing CSV consultancy and training Services to Major life sciences and equipment/Software developer companies.
Currently working on a serialization project for one of the pharma equipments and software development client. My role is to prepare and provide all the required CSV documents and halp their development to team to develop the software in line wif GAMP-5 and USFSA 21CFR PART-11. Project is in PQ phase.
Providing 2 days training session on CSV and data integrity, scheduled for 50 employees of the software company.

Confidential

Manager

Responsibilities:

Primarily responsible for Computer System Validation of all the computerized system installed in Dehradun plant.
Reader on: - Current Technology Requirements of Industry, Current Compliance requirement and changes (GAMP-5, CGMP, USFDA 21 CFR Part-11). FDA warming letters.
Technology and System Up-Gradation Advisor to President- Corporate Quality, Six Systems Compliance Operations for Plant and R&D and Regulatory Affairs
CSV Project Planning And Management for newly installed computerized system
Review and approval of CSV documents Such as VMP, RAP, FRA, IQ, OQ, PQ, GxP Assessment and VSR
Responsible for CSV Periodic review of all computerized system installed in Dehradun plant such as process control system (PLC/SCADA/HMI), laboratory equipment software, ERP and BMS and Compilation and preparation of CSV Audit and evaluation Report.
Provide CSV execution and documentation training.
One of the Key project member of serialization incrimination team