Validation Lead Data Platforms

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The Position

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. Everyones 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.

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.