Senior IT Analyst, Compliance and Validation EnVivo Pharmaceuticals
As a key member of the IT team, this individual will be responsible for managing all aspects of the company?s compliant IT infrastructure, creating a strategic plan to support future activities, and day to day support of new compliant systems, changes, and process documentation. One key role of this position is to maintain tight communication between IT and QA, and to ensure alignment of activities between groups for current and future projects.
This position reports to the Director of Information Systems Management.
Position Responsibilities & Tasks
This position will be primarily responsible for the management of regulated IT activities.
Responsibilities and essential functions include:
Relationship management ? maintain alignment between IT, QA and other relevant departments
Communications ? maintain tight communications between IT, QA, and others with verbal, written, and other forms of communication as necessary, i.e. presentations, emails, etc.
Strategic planning ? Develop an overall IT plan and processes for the management of compliant systems with a focus on minimizing the impact of regulated activities on the corporate IT infrastructure
Project management ? align activities and maintain timelines between departments for new rollouts, configurations, validations, etc.
Compliant systems management ? perform validations, change control, IQ/OQ/PQ testing, signoff, etc. Work with internal departments and external vendors as necessary. Utilize processes developed in the strategic plan.
Supporting documentation and activities ? develop SOPs, gain signoff, perform training, etc. as necessary.
At least five years to 8 years experience performing similar duties in the pharmaceutical industry
Deep understanding of all relevant regulations (GxP, 21 CFR 11, etc.), their applications to the management of compliant systems, and a diligent attitude to keep up with regulatory information publications
Experience in all phases of pharmaceutical development to which such regulations apply
Bachelor?s degree in computer science, information systems, or related technical discipline
Master?s degree preferred
The ideal candidate would have started off in an unregulated IT environment and managed the transition to a partially regulated one
Excellent written, verbal, and electronic communication skills
Project and time management skills
Experience developing in SharePoint to support required activities
Experience with MS Project
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