IT Senior Professional - Quality Engineer (Validation)
IT Senior Professional - Quality Engineer (Validation)
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1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
Thats what makes us Roche.
The Opportunity
At Roche compliance is our license to operate and we are committed to delivering high-quality products. Every contribution you make will impact patients as patient safety is at the forefront of everything we do.
In this you require strong expertise in IT validation within the healthcare domain and solid software testing experience combined with the ability to work independently engage with diverse stakeholders and drive quality assurance best practices across complex initiatives you will play a pivotal role in ensuring the quality of the products we deliver. In this role you will have the opportunity to lead quality in AI innovative initiatives with strategic relevance.
You will be part of a highly motivated collaborative and diverse Quality Engineering Cluster where you will be able to develop yourself and coach and mentor others.
You will identify process gaps and inefficiencies within testing validation and delivery processes propose improvements and champion quality engineering best practices to guide and mentor the product team.
You will review or ensure the creation of deliverables from Test Managers and Validation Leads for GxP-relevant systems upholding an oversight role while maintaining segregation of duties.
You will evaluate and prioritize automation opportunities in testing and validation collaborate with Test Automation Experts (TAEs) to implement solutions and Proof of Concepts.
You will foster a culture of continuous improvement by identifying enhancements in the SDLC processes through feedback analysis and applying best practices including performing maturity assessments.
You will ensure validated systems remain audit-ready by managing IT controls such as change/configuration management access/security audit trails and backups while leading periodic system reviews.
You will lead quality investigations by driving deviation investigations conducting root cause analyses defining CAPAs and acting as a CSV subject matter expert during audits and inspections.
You will champion compliance by safeguarding system validation and alignment with company procedures maintaining readiness for internal and external audits.
Who you are:
You will hold a bachelors degree in Computer Science Engineering Life Sciences or a related field with 35 years of experience in Quality Engineering within GxP-regulated environments (e.g. pharma biotech MedTech).
You will author validation strategies product delivery strategies test plans reports and deliverable registries.
You will review validation and testing deliverables records and related documentation including key system evidence.
You will maintain and support applications to ensure compliance with global audit and inspection agencies.
You will demonstrate strong regulatory knowledge including FDA (CFR 21 Part 11) Annex 11 EU GMP Annex 1 MHRA (Data Integrity) and GxP practices.
You will possess a good understanding of cloud-based platforms (i.e. SaaS PaaS) EDMS (e.g. Veeva) ALM tools (e.g. JIRA RETINA) and have familiarity with AI/ML tools and applications as an advantage.
You will bring expertise in system and data risk assessment understanding of Agile methodologies (e.g. SAFe Scrum) and the ability to work collaboratively in cross-functional and agile teams.
You are an effective communicator with excellent verbal and written proficiency in English and exhibit assertiveness leadership conflict-handling skills and the ability to work with diverse personalities and cultures.
**Relocation is not eligible for this position**
Who we are
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Employment Type
Full-Time
