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IT Validation Lead- Data Platforms
Preferred Location: Pune
The Opportunity:
In Roche, compliance is our license to operate so we are committed to the quality of the product we deliver. Everyone's contribution will have an impact on patients, so in everything we do, we think about patient safety.
Following our validation risk-based culture, as an IT Validation Lead, you will play a big role in ensuring the quality of the product we deliver. You will be responsible for the evaluation, design, development, and approval of validation plans, protocols, and reports, for computerized systems mainly focusing on the Data and Application Integration domain.
In liaison with the Quality Assurance and product team, you will help to ensure products are manufactured, implemented, and maintained in accordance with the appropriate regulatory agency validation requirements, our company standards, and current industry practices.
You will closely work with the product and Software Quality Assurance (SQA/Testing) team in defining the test strategy and coverage and reviewing/approving test results. You will continuously assess/review internal validation processes and procedures, making recommendations for improvements.
As the IT Validation Lead- Data Platforms, you are responsible for:
Determine validation approaches and identify 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
Provide 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.
Who You Are:
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
Minimum 5+ years experience in IT & Software Validation (CSV/CSA, GAMP).
Experience leading validation in projects and system maintenance in various areas.
Experience in leading small validation teams.
Experience with project management, CSV, Software Development Lifecycle Models in pharmaceutical industry or related.
Experience in the quality maintenance and support of regulated applications.
Technical Skills
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.
Understanding of Data and Application Integration concepts and solutions would be an advantage.
Additional Qualifications
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.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.