Project Manager

? Business Analysis of various Quality processes including Event Management,
CAPA?s and Change of Control processes. ? Implementing and automating business
processes into the Trackwise solutions. Functional expertise in Sparta
System?s TrackWise including configuration and administration tools (Administrator
and Coordinator). ? Expertise in applications deployment in a Windows environment.
? Expertise in Reports design and development in Crystal Reporting preferred.
? Working knowledge of Mercury Quality Center for creation of program-level
computer systems validation documents (Validation Plans, Requirements,
Reports) ? Development of all associated documents including qualification
, test plans and User Acceptance Tests and protocols for GAMP-based validation
of quality computer systems, ? Life Science manufacturing and systems regulations
(21 CFR Part 11, GxP etc) ? Understanding of Software Development Lifecycle
Practices ? In addition, the incumbent would be required to support troubleshooting,
bug-fixes and resolution of any User requests, problems and issues related
to Trackwise. Should be familiar with Release Management, Change Management,
Validation documentation compliance, Configuration Management, Capacity
Management, Incident Management, Problem Management, Continuity Management
and Application Security.

Requirements

? A minimum of 3 years of Quality processes and systems experience in a
regulated environment is required ? B.S in Life Sciences or Computer Science
desired. ? Certification or experience with TrackWise configuration and
deployment tools (Administrator, Coordinator) ? Operational experience
with Web-based applications in a Windows server environment ? Reports development
experience (Crystal preferred) ? Capable of working independently and within
a team ? Strong communication and documentation abilities and very strong
Word and excel. ? Excellent written and verbal communication skills and
critical thinking abilities are a must The candidate must be a self-starter
able to excel in a fast-paced environment with little supervision

Apply for this Job at:
http://www.net-temps.com/job/1bc2/10-05753/project_manager.html?r=aje

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