Hiring For Validation Engineers (QA)

Roche Information Solutions

3 - 6 years

11 - 21 Lacs

Pune

Posted:1 month ago| Platform:

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Skills Required

21 Cfr 21 Cfr Part 11 software validation Csv Gamp Gxp

Work Mode

Hybrid

Job Type

Full Time

Job Description

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team.

Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field
Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP)
Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices)
Good understanding of system and data risk assessment
General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage.
Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals
Effective communicator with excellent verbal and written communication skills - English language mandatory
Assertiveness and ability to work with diverse personalities/cultures

Lets find out what a usual day of work might look like. You will:

Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems
Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance
Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live
Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures
Support in deviation investigations to identify root causes and define corrective and/or preventative actions
Support system audit/inspection preparation and execution as CSV subject matter expert
Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready
Support system periodic reviews according to company procedure

We offer:

dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.)
a workplace that supports innovation and new ideas
attractive benefits & business travel opportunities
work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow

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