29 Aug
|
Artech Infosystem Private
|
Bengaluru
29 Aug
Artech Infosystem Private
Bengaluru
Client: One of the leading consulting Tier 1 firm
Title: Computer System Validation(CSV)
Experience: 4 – 14 years
Location: Hyderabad, Bengaluru, Chennai, Pune
Note: This is a Contract-to-Hire (C2H) opportunity. Please apply only if you are comfortable with a C2H engagement model and can join within 10-15 days of selection.
Kindly share your updated resume at
[email protected] along with your notice period/availability to join (Immediate to 15 days preferred).
Required Qualifications
Experience with GxP-regulated systems and computer system validation.
Working knowledge of GAMP 5, CSA, data integrity, and risk-based validation.
Experience with validation documentation, traceability, testing, deviations, change management, and audit readiness.
Experience working with SaaS, cloud-hosted applications, or qualified cloud infrastructure.
Strong experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA) in agile delivery environments.
Experience applying a risk-based validation approach to Agile releases, features, user stories,
and product increments
Experience integrating quality, compliance, and validation activities into Agile and hybrid SDLC frameworks
Experience in IT quality, IT compliance, IT risk management, and quality oversight
Robust stakeholder coordination, documentation, and delivery-management skills..
Practical knowledge of infrastructure and network components, including servers, virtual machines, storage, databases, load balancers etc.
Understanding of cloud service models, including IaaS, PaaS, SaaS, hybrid cloud, and managed services
Key Responsibilities
Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance principles, focusing effort on patient safety, product quality, and data integrity.
Lead validation lifecycle activities for GxP-regulated systems, including requirements, specifications, traceability, testing, deviations, change control, CAPA s
📌 Computer System Validation Consultant (Bengaluru)
🏢 Artech Infosystem Private
📍 Bengaluru