Overview
On Site
Full Time
Skills
SCADA
Programmable Logic Controller
URS
DS
DirectShow
IQ
OQ
PQ
GxP
Computerized System Validation
GAMP
Verification And Validation
Change Management
Documentation
Process Control
Project Planning
Risk Assessment
Traceability Matrix
Standard Operating Procedure
Management
Reporting
Job Details
Summary :
Roles & Responsibilities:
- Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
- Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
- Author documents related to GxP Systems
- Draft Requirements and computer systems validation documents using GAMP 5
- Execute test protocols for the software validation.
- Initiate and execute change management for existing qualified systems.
- Develop change management record, create or revise documentation if required, and execute implementation tasks.
- Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
- Maintaining the project plan/schedule to meet deliverable commitments.
Roles & Responsibilities:
- User and Configuration Specifications
- System Impact Assessments
- Risk Assessments
- Installation Qualification Protocols
- Operation Qualification Protocols
- Performance Qualification Protocols
- Traceability Matrix
- Summary Reports Standard Operating Procedures
- Authoring Change Controls
- Authoring and executing test protocols
- Managing Issue Reporting, Deviations and related CAPAs
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