Job CSV Validation Consultant Massachusetts CSV Validation

CSV Validation Consultant

Skills:CSV Validation       |  Location:Massachusetts  ,  United States Of America

Views:487


POSITION :
CSV VALIDATION CONSULTANT
LOCATION:
RAYNHAM, MA
DURATION: 6+
MONTHS CONTRACT

JOB DESCRIPTION:

MANDATORY: LIFE SCIENCES ? PHARMA/ MEDICAL DEVICES PROCESSES /
PROJECTS ESPECIALLY-21 CFR PART 11, CGXP SYSTEM, IQ/OQ/PQ

B.S. /M.S. in IT/Engineering or equivalent with 5+years of experience
in Computer System Validation with Life sciences - Pharma/ Medical
Devices processes / projects especially-21 CFR part 11,
Coordinate between Buyer stakeholders, Subject Matter Experts
("SME/s")
Interact with Buyer, understand their requirement & provide
delivery team with client expectations
Work closely with project leaders on collaborating and collecting
the right inputs
Create and update documents relating to CSV activities per SDLC
methodology.
Draft and maintain cGxP system lifecycle documentation, including
validation plans, User Requirements (URS), Functional and Design
Specifications, Testing Protocols (IQ/OQ/PQ), traceability matrix,
validation reports, SOPs, change control documentation, risk
assessments, and validation summary reports.
Reviewing completed protocols for completeness, cGxP compliance
and data acceptability; compiles final data-pack.
Responsible for tracking and maintaining deliverables

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