Medical Device/Pharma/Bio Pharma Experience is must

Responsibilities:

• Conduct Software Quality Assurance (SQA) with a focus on reviewing and approving Software Development Life Cycle (SDLC) deliverables.
• Previous experience in SDLC/Software Validation, including writing and executing SDLC deliverables such as MVP testing.
• In-depth knowledge of Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Traceability Matrix, and System Release.
• Several years of SQA experience, particularly in reviewing and approving SDLC deliverables like MVP, Risk Assessment (FMEA), IQ, OQ, PQ, Traceability Matrix, and writing System Certifications.
• Provide SQA support for the review, approval, and implementation of regulated IT applications.
• Collaborate with the development team to integrate compliance capabilities, ensuring the quality of deliverables meets business needs.

Qualifications:

• Strong validation expertise with over 7 years of experience.
• Ensure IT validation packages are inspection-ready and comply with company policies and procedures.
• Previous experience in automated testing and implementation.
• Proficient in understanding GxP regulations and validation principles.
• Solid experience in reviewing CAPAs, Change Control, and Defects in relation to Software Validation.
• Familiarity with various applications and tools such as JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera, Qtest, M-Files, or other continuous integration tools.
• Understanding of the differences between Waterfall and Agile software development methodologies.