Job Description

About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSRs expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!About Illumina:Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Illuminas integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If youre eager to work on challenging projects that uses cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team.Responsibilities:

• Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
• Operate independently to manage end to end compliance activities within projects.
• Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
• Responsible for Validation Documentation.
• Participates in project and system requirements gathering/authoring, coordinates activities with business users and analysts.
• Coordinates the Change Management process within the GIS organization.
• Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
• Investigates root-cause of defects, failures, and authors and/or investigates Non-conformances and CAPAs.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Requirements:

• 8+ years of experience working in Life sciences industry focusing on Computer Systems Validation.
• Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
• Strong organizational skills to maintain and manage multiple validation projects.
• Experience with any enterprise applications such as SAP, LMS, Salesforce and EtQ, etc are good to have.
• Experience with Test Management Tools such as HP Quality Center, ValGenesis and TFS etc.
• Ability to articulate risk-based validation strategy and provide validation approach to meet the business needs.
• Excellent customer service and communication skills.
• Experience with regulations and frameworks e.g., 21 CFR Part 820/11, ISO 13485, and GAMP.
• Experience with software development lifecycle activities, methodologies, testing and validation.
• Experience managing workload using IT Service Management ticketing tools, ServiceNow preferred.
• Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.

People Leadership:

• Ensure Policies and Procedures are followed by direct reports
• Work with onshore leads for new and/or altering work assignments

Experience / Education:

• Typically requires a minimum of 8 years of related experience with a bachelors degree; or 5 years and a Masters degree

Leading-Biotechnology-Company