Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a global leader in biopharmaceuticals, and they are seeking a Specialist/SR Specialist in PV Systems and Data Analysis. The role involves executing activities related to Global PV processes, ensuring compliance, and acting as a Subject Matter Expert for PV Systems.
Responsibilities
- Subject Matter Expert for PV Systems
- Implements PV Systems Change Controls
- Provides guidance and support for PV Systems Administration for all environments (dev, val, prod, train)
- Guides and trains Users with system use and data retrieval needs
- Leads the Change Advisory Board
- Responsible for investigating and resolving Level 2 system issues
- Ensures system remains compliance with corporate procedures and multiple regulatory authorities’ requirements
Skills
- Bachelors degree (e.g. Biology, Statistics, IS/IT) from an accredited institution
- Minimum of two (2) years of experience or five (5) years of experience working within a GMP/Compliance environment with a focus on data analysis
- Experience working with PVWorks, Trackwise or similar validated databases
- Experience working with databases and database system support
- Must have Regulatory and/or Compliance experience
- Demonstrated experience using SQL and SQL Software tools, Qlikview and/or statistical software tools and Crystal Reports
- Working to develop knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines
- Must have ability to remain calm under pressure and work to meet strict regulatory and customer driven timelines
- Demonstrates problem solving skills including prioritization, innovation and creativity, managing information from multiple sources both internal and external
- Must ensure compliance requirements are met for different regulatory authorities worldwide with varying requirements
- Responsible for advanced system administration activities and escalates to Principal Specialist or Manager of PV Systems if configuration changes are needed
- Develops new report queries/formats and executes routine reports
- Supports PV System projects under direction of Principal Specialist and/or PV Systems and Data Analysis Manager
- Proficiency with Microsoft Office products, specifically advanced graphing in Excel
- Demonstrated experience with computer systems validation deliverables and change control documentation
- Excellent oral and written communication skills and an ability to operate effectively in a global and team environments and to build consensus
- Attention to detail, quality focused and strong technical and problem solving skills
- Must have excellent organization and time management skills
- Ability to manage conflict and provide solutions to balance business needs with user friendliness
- Ability to think and work creatively and independently, under pressure, demonstrating initiative and flexibility
- Fluent in spoken and written English
- Advanced degree (e.g. MSc, MBA)
Company Overview
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