Add office photos
All Filters
18 Roche Diabetes Care Jobs
IT Validation Professional
Roche Diabetes Care
posted 3mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Opportunity:
As an IT Validation Professional, you will play a crucial role in ensuring the quality of our products. Your responsibilities will include evaluating, designing, developing, and approving validation plans, protocols, and reports for computerized systems across various domains and product lines. In collaboration with the Quality Assurance and product teams, you will ensure that products are manufactured, implemented, and maintained in compliance with regulatory agency validation requirements, company standards, and current industry practices.
You will work closely with the product and Software Quality Assurance (SQA/Testing) teams to define test strategies and coverage, as well as review and approve test results. Additionally, you will continuously assess and review internal validation processes and procedures, making recommendations for improvements.
You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance/Validation Team.
As an IT Validation Professional, you will be 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
- 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.
- Over 3 years in IT & Software Validation (CSV/CSA, GAMP).
- Familiarity with FDA regulations/guidance (CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).
- Understanding of system and data risk assessment, and general knowledge of Agile Methodology (SAFe, Scrum).
- Strong communication skills, ability to work in cross-functional and agile teams, and assertiveness in diverse environments.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we ve become one of the world s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Professional roles with real interview advice
People are getting interviews at Roche Diabetes Care through
People are getting interviews through
(based on 4 Roche Diabetes Care interviews)
Referral
Recruitment Consultant
25%
25%
50% candidates got the interview through other sources.
Moderate
Confidence
?
Moderate Confidence means the data is based on a sufficient number of responses received from the candidates
What people at Roche Diabetes Care are saying
What Roche Diabetes Care employees are saying about work life
based on 78 employees
Flexible timing
Alternate Saturday off
Within city
Day Shift
Roche Diabetes Care Benefits
View more benefits
Compare Roche Diabetes Care with
Abbott Diabetes Care
Compare
Medtronic
Compare
Dexcom
Compare
LifeScan
Compare
Sanofi
Compare
Novo Nordisk
Compare
Ascensia Diabetes Care
Compare
Vcare Trichology
Compare
XL Health
Compare
Suburban Diagnostics
Compare
DCDC Kidney Care
Compare
Apollo Clinic
Compare
Ruby Hall Clinic
Compare
ESIC HOSPITAL
Compare
Sir Ganga Ram Hospital
Compare
Apollo Diagnostics
Compare
Fresenius Medical Care
Compare
Oncquest Laboratories
Compare
Boston Scientific
Compare
Venkateshwar Hospital
Compare
Similar Jobs for you
Share an Interview