At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. We have 6500 people across the world innovating, creating, and delivering quality healthcare collaboratively, while employing the highest levels of ethics and integrity, every day. We have been listed in the Top 10 Bio-Pharma Companies to Work For more than once by Science Magazine, including this year. KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following mostly focusing on L1 and L2 support for Veeva Vault QMS. Coordination with OEM partners for L3 support. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA’s defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor’s in Engineering or Master’s degree in a related discipline, including a minimum of 2-4 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Veeva QMS administration experience – preferably with Veeva certification. Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight. Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.
