- Help develop and implement technology architecture and system integrations in the Quality and Regulatory Affairs functions of Life Sciences companies
- Review project teams' technical output from a quality standpoint, perform code reviews, oversee defect density report production etc. as well as ensure functional requirements are translated to technical requirements correctly
- Work with Client's business and IT teams to understand business requirements and user stories.
- Develop system integration specifications and technical design to meet defined requirements and user stories.
- Develop Solution Architecture and Integration based on client's IT landscape and interface requirements
- Draft interface design and specifications document
- Develop or configure required integration services
- Build integration services on client's preferred middleware tool
- Conduct demo/playback sessions with client's business and IT teams.
- Support the creation and execution of unit testing and Operational Qualification test scripts and defect resolution.
- Work directly with end clients (including participation in new engagement acquisition work)
- Scan the market for trends in these areas as well as keep him/herself updated on broad LS trends
- Support scoping of new opportunities specific to LS technology operations
- Provide pre-sales support by way of presentations and PoCs to new opportunities in the tech implementation space for LS clients
- 10+ years with at least 5 years of hands-on experience in tech configuration space working for LS / medical devices clients
- Hands - on experience implementing technology architecture and integrations with any of the following systems in the Life Sciences Quality/Regulatory domain: Veeva, Sparta Trackwise, Rimsys and IQVIA
- Experience in configuration of LS packaged solutions
- Experience in Salesforce platform
- Experience in Data Identification, Extracting, Transformation and Load
- Experience integrating Quality and Regulatory technology solutions with other enterprise systems (SAP, PLM, Data Warehouse, etc.)
- Experience being part of an agile software development team
- Experience with developing Functional/Configuration specifications and validation (IQ/OQ/PQ) test scripts for implementing application functionality.
- Certifications in Life Sciences for US market
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Tech Architecture - Bangalore Urban, India - KPMG India
Description
KPMG Global Services (KGS) India is a strategic global delivery organization that works with more than 50 KPMG firms to provide a progressive, scalable and customized approach to business requirements.
The KGS India journey has been one of consistent growth, with a current employee count of c.21,000, operating from eight locations in India — Bengaluru, Gurugram, Hyderabad, Mumbai, Kochi, Noida, Pune and Kolkata. — and providing a range of Advisory and Tax-related services to KPMG firms around the world.
Roles and responsibilities
Required Education / professional qualifications
Bachelors / Masters from a reputed college
Prior Experience:
The candidate must have 10+ years of relevant experience in a similar role, working with life sciences companies.
Experience & Background