Overview
On Site
Full Time
Skills
Quality Assurance
Software Development Methodology
Specification Gathering
IQ
OQ
PQ
Collaboration
Regulatory Compliance
Confluence
GxP
GAMP
ISO 13485
ISO/IEC 27001:2005
Quality Management
Test Management
Trackwise
Veeva
Application Lifecycle Management
JIRA
Data Integrity
Auditing
SaaS
IaaS
PaaS
COTS
Job Details
Responsibilities:
- Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc.
- Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met.
- Review of CAPAs, Change Controls and Defects for GxP applications.
- Working with Global teams and providing audit support.
- Working with a range of applications/tools including ALM, TrackWise, JIRA, Confluence, and other integration tools.
- Bachelors with 8+ years of exp. or Master's with 5+ years of exp prefered.
- Prior experience in regulated industry - GxP systems.
- Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001.
- Quality Management Tools and Test Management Tools - TrackWise/ComplainceWire/Veeva, ALM, JIRA etc.
- Knowledge about Data Integrity and prior audit support experience (Internal/External).
- Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications.
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