Computer System Compliance Consultant Resume

SUMMARY:

Experienced in Confidential. Successfully executed and completed Confidential - Audit, training, Projects, Gap Assessments, Gap remedies and International Audit support in 40+ well known life science companies.

TECHNICAL SKILLS:

IT Infrastructure
Laboratory Equipment Software
SAP/ERP
QMS/DMS
Data Centers
Serialization System
PLC/SCADA/ Process Control System.
MCC
BMS/EMS
CSV Audit and Gap Assessment
CSV Audit Support in an international Audit
CSV, Data integrity and GAMP-5 Training

PROFESSIONAL EXPERIENCE:

Computer System Compliance Consultant

Confidential

Responsibilities:

Working as a fulltime computer system compliance and Confidential consultant independently.
Providing Confidential 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 Confidential documents and help their development to team to develop the software in line with GAMP-5 and USFSA 21CFR PART-11. Project is in PQ phase.
Providing 2 days training session on Confidential and data integrity, scheduled for 50 employees of the software company.

Confidential

Manager- Computer System Validation

Responsibilities:

Primarily responsible for Computer System Validation of all the computerized system installed in Dehradun plant.
Technology and System Up-Gradation Advisor to President 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 Confidential documents Such as VMP, RAP, FRA, IQ, OQ, PQ, GxP Assessment and VSR
Responsible for Confidential 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 Confidential Audit and evaluation Report.
Provide Confidential execution and documentation training.
One of the Key project member of serialization incrimination team

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