We are seeking an experienced Software Lifecycle and Compliance Specialist to manage the review, approval, and audit readiness of software lifecycle (SLC) deliverables for regulated applications.
This role requires close collaboration with cross-functional teams to ensure compliance with industry standards while meeting business needs.
The ideal candidate will have hands-on experience with GxP systems, quality management tools, and audit processes in a regulated environment.
Key Responsibilities :
- Review and approve software lifecycle (SLC) deliverables, including :
- Risk classifications
- Requirements
- Configuration and design specifications
- IQ, OQ, PQ protocols
- Traceability matrices and summary reports
- Collaborate with cross-functional teams to build compliance capabilities and ensure quality deliverables meet business needs.
- Review CAPAs, Change Controls, and defects for GxP applications.
- Provide audit support (internal and external) and work with global teams to ensure compliance readiness.
- Utilize tools and applications such as ALM, TrackWise, JIRA, Confluence, and other integration platforms.
Required Education and Experience :
- Bachelor’s degree with 8+ years of relevant experience, or
- Master’s degree with 5+ years of relevant experience.
- Note : Resumes must include the graduation year for either the Bachelor’s or Master’s degree.
Top 5 Skills / Requirements :
Experience in regulated industries with GxP systems.
Strong knowledge of FDA regulations :
- 21 CFR Part 11, Part 820, Annex 11
- GAMP5, ISO 13485, ISO 27001
Proficiency with Quality Management Tools and Test Management Tools , such as :
- TrackWise, ComplianceWire, Veeva
- ALM, JIRA
Experience in data integrity and providing audit support (internal / external).
Exposure to various software models, including :
- Software as a Service (SaaS)
- Infrastructure as a Service (IaaS)
- Platform as a Service (PaaS)
- COTS (Commercial-off-the-shelf) and custom applications
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