Title: Project Manager
Location: Client Sites (North East)
Responsibilities: Role involves working with an IT consultancy and supporting pharmaceutical clients on validation projects, specifically in relation to Regulation 21 CFR 11 compliance. The ideal candidate should have demonstrated Project and Program Management skills in an IS function within an IT consultancy servicing pharmaceutical clients and/or worked as an internal capacity within the pharmaceutical industry. Should have "hands-on" working knowledge of (technical) systems implementation, application development and design, together with an understanding of change management and process improvement issues.
Education/Experience:
BS in engineering, technical or systems related area. MBA or MS within an appropriate technical area is a plus.
5-10 years experience in IT functions within the pharmaceutical or other regulated industry.
Conducting software vendor audit (Peregrine FacilityManager - a plus if
consultant has knowledge of this package but not a requirement)
Developing/writing validation plans
Assessing systems relative to the validation plan and documenting results
Developing remediation plans
2 years of experience in project and program management.
Experience in managing large programs
Proven FDA validation experience required.
Qualifications:
Excellent leadership and matrix management skills.
Ability to effectively communicate with all levels in the organization.
Mature project management and problem solving expertise.
Ability to work in a large, multi cultural environment.
Excellent understanding of quality processes and quality systems as related to the architecture, development, implementation, and maintenance of computerized systems.
To apply for a current position, please submit your details via the Application section of this site.
PLEASE NOTE:
Only suitably qualified candidates will be considered and contacted due to the
volume of resumes we receive
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