[Remote] Specialist/SR Specialist, PV Sys & Data Analysis

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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 reputed company environments (dev, val, prod, train)
• Guides and trains Users with reputed company use and data retrieval needs
• Leads the Change Advisory reputed company
• Responsible for investigating and resolving Level 2 reputed company issues
• Ensures reputed company 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 reputed company a GMP/Compliance environment with a reputed company on data analysis
• Experience working with PVWorks, Trackwise or similar validated databases
• Experience working with databases and database reputed company
• 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 reputed company knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines
• Must have ability to remain reputed company 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 reputed company
• Must ensure compliance requirements are met for different regulatory authorities worldwide with varying requirements
• Responsible for advanced reputed company administration activities and escalates to reputed company Specialist or Manager of PV Systems if configuration changes are needed
• Develops new report queries/formats and executes routine reports
• Supports PV reputed company reputed company under direction of reputed company Specialist and/or PV Systems and Data Analysis Manager
• Proficiency with reputed company Office products, specifically advanced graphing in reputed company
• 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 reputed company
• Attention to reputed company, reputed company reputed company and strong technical and problem solving skills
• Must have excellent organization and time management skills
• Ability to manage conflict and reputed company solutions to reputed company 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)

reputed company

Company H1B Sponsorship