Validation Engineer

Suniksha Infotech

7 years

0 Lacs

india

Posted:2 days ago| Platform:

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Skills Required

software inspection risk controls support development compliance drive strategy fmea management agile testing jira confluence tosca qtest aws databricks data github communication

Work Mode

Remote

Job Type

Contractual

Job Description

Role: Software Quality Assurance (SQA) – Contract

Type
: Contract
Location
: Remote
Experience
: 7+ years in Validation/SQA
Availability
: Immediate joiners only

Key Responsibilities

Ensure IT validation packages are inspection-ready and compliant with company policies and procedures.
Act as SQA reviewer and approver for SDLC deliverables (MVP, Risk Assessments, Requirements, IQ, OQ, PQ, Trace Matrix, System Certification).
Review CAPAs, Change Controls, and Defects as related to Software Validation.
Support implementation of regulated IT applications.
Collaborate with development teams to build compliance capabilities and ensure business needs are met.
Drive continuous improvement and contribute to validation strategy for IT changes.
Work independently with IT teams and business SMEs to maintain compliance.

Requirements

Proven experience validating systems in a
GxP-regulated environment
(Pharma/Life Sciences).
Hands-on experience authoring and executing SDLC deliverables (MVP, FMEA, IQ/OQ/PQ, Trace Matrix, System Release).
Strong background in SQA review and approval of validation deliverables.
Knowledge of risk management principles, regulatory requirements, and industry best practices.
Solid understanding of Waterfall and Agile methodologies.
Experience with automated testing and implementation.
Familiarity with tools: JIRA, Confluence, HP-ALM, Tosca, Veera, Qtest, M-Files. Exposure to AWS, Databricks, Data Lake, GitHub or CI tools is a plus.
Strong analytical, written, and verbal communication skills; confident in meetings and inspections.
Highly self-motivated and capable of working with minimal supervision.

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