Job Description

Work Your Magic with us! Ready to explore, break barriers, and discover more We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That\'s why we are always looking for curious minds that see themselves imagining the unimaginable with us. Job Location: Electronic City, Bangalore : The R&D Application team supports the delivery of the R&D service Portfolio for the HealthCare Research (Global Discovery Technology, Global Early Development, External Innovation, Patents & Scientific Services) and Development (Strategic & Business Operations, Global Clinical Development, Global Regulatory Affairs & QA, Global Medical Affairs & Safety). You will work within the Information Technology (IT) group, as part of the Healthcare R&D domain organization. As Sr. Compliance Specialist, you enable the application delivery team to stay compliant by providing efficient approaches and Services. Responsibilities: Review and provide input into SDLC documents for R&D GxP applications Work closely with theIT Quality and R&D Quality QMS to support development of R&D policies and procedures related to electronic systems and digital technology activities. Develop and maintain Audit Readiness Plans for the R&D Digital & Data Transformation. Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained. Actively participate as a key member of the audit readiness team for audits and inspectionsas it relates to GxP R&D systems Provide expert guidance and direction in the development of responses to Regulatory Authority inspection findings for inspections of Healthcare R&D systems. Contribute in the continuing awareness of a quality culture at R&D Digital & Data Transformation. Be the accountable point of contact in matters associated with Audit management within R&D Digital & Data Transformation. Supports internal and external GxP audits as required including drafting audit responses in coordination with department management and subject matter experts. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance Establish strong working relationships with vendors (eg, CDMOs, CROs) and provide appropriate Quality oversight, including establishing vendor qualification processes, vendor audit plans, quality agreements and quality performance metrics Minimum Qualifications: Minimum of 5-10 years of experience Minimum of Bachelors Degree or applicable experience within information systems with focus on audit readiness and Computer System Validation of R&D applications Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable regulations, guidelines and local legislation. Knowledge of relevant FDA, EU, guidance for GCP, GLP, GPV. Experience working with CROs, vendors, and relationship management. Experience supporting regulatory authority inspections and developing responses to regulatory authority inspection findings. Thoroughly familiar with Quality & GxP IT compliance requirements Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information Strong analytical skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance, while identifying areas for improvement Excellent analytical skills sufficient to lead complex problems resolution, make accurate and consistent interpretations and present high-level reporting for weekly operations meetings and monthly service reviews. Ability to familiarize himself / herself independently with entirely new subjects and thus provide comprehensive and innovative solutions Excellent written and verbal communications skills Proven fast learning & problem management skill What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

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