Job Description

JOB DESCRIPTION: Primary Job Function The I&D Operational Excellence Specialist supports the efficient and compliant execution of I&D activities to internal and external standards by supporting I&D quality system, training and governance activities. Core Job Responsibilities Governance Support compliance and quality control activities for global I&D - tracking and conducting self-inspection activities in line with department self-inspection plan Maintain department quality and compliance metrics Ensure I&D records comply with global guidelines and applicable regulations Perform quality control review of documents (e.g. check content consistency, pagination, spelling grammar, referencing, formatting etc.) Support internal and external inspection activities as required Training Support the implementation of training activities Support implementation and maintenance of documentation and training systems I&D Manage I&D training metrices Maintain I&D user training matrix and curricula Prepare I&D quality system documents and liase with DARIUS Quality group to prepare document package for new/ revised quality documents Content upload/ course creation in training system (ISOtrain) for I&D Assign training in the system Acts as super user for selected systems System set up of ISOtrain training records for (profile creation, curricula assignment) Support preparation of onboarding packages for I&D Supervisory /Management Responsibilities Direct Reports: NA Indirect Reports: NA Position Accountability / Scope: Responsible for document quality control reviews & self-inspection activities Responsible for supporting I&D training activities Internal stakeholders Medical Office (Medical Affairs, Clinical Development and Pharmacovigilance), Quality Assurance, Regulatory Affairs, Office of Ethics and Compliance, global, regional and local External stakeholders business partners (contractors, consultants, vendors) Minimum Education Bachelor of Science in a field related to life sciences or equivalent by experience Experience: At least 3-years\' experience in pharmaceutical industry Understanding of GxP principles Experience with working in a Global fast paced environment Attention to detail, organized, capable of multi-tasking, capable of working independently Proficient in MS office applications especially Excel and Word Experience of quality control and/or training preferable Fluent in English The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Medical & Scientific Affairs DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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