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GXP Systems, Contractor
Job Description
*Depending on experience
POSITION SUMMARY:
The Analyst of IT GxP Systems Contract provides direct support to business stakeholders for GxP systems by creating and implementing innovative, relevant principles and technical solutions to support initiatives and ongoing activities. The position will be supervised by IT Business Partner for GxP systems.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
· Technical support for Veeva, Compliance Wire, Argus and Tracelink releases
· Technical support for DocuSign GxP
· Technical support for migration of Regulatory documents from various non-GxP systems into Veeva Submissions Vault
· Ensure compliance with all system and process changes to support GxP activities.
· Team member on various business funded IT projects. Work with and support business members of the team
· Computer System Validation activities
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
· Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
· Minimum of a Bachelor’s degree preferred or equivalent with at least 6 years’ technical experience (an equivalent combination of experience and education may be considered)
· Previous experience in a Business System Analyst role
· Strong GxP Systems Testing and IT Implementation experience.
· Demonstrated Project Management experience.
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required:
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software preferred: Veeva Vault (QualityDocs, QMS, RIM, and Submissions), TraceLink, and Argus. Additionally, knowledge of Smartsheet, MS Project, Visio, SharePoint and Teams are a plus.
INTERNAL AND EXTERNAL RELATIONSHIPS:
· IT
· Quality
· Safety
· Regulatory Affairs
· Regulatory Operation
· Supply Chain
· Veeva Managed Services
*CO/NYC candidates might not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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