Senior Validation Specialist with Pharmaceutical Experience

Company Name:
Alpha Consulting Corp.

OCTOBER 24, 2014

Project Description:
6+ years' experience
Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
Follow SOPs and industry best practices
Conduct training on good documentation and good testing practices
Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
Review validation deliverables for projects which are contracted to third party suppliers
Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
Assist in planning, implementing, and documenting user acceptance testing
Review computerized systems validation documents such as:
Requirements Specification
Design Specification
CSV Risk Assessment
Test Plans
Test Summary Reports
Data Migration Plan
Pre / Post Executed Test Scripts
Traceability Matrix
Release to Production Statements
Direct and review testing
Provide guidance on quality issues that affect the integrity of the data or the system
Prepare validation summary and test summary reports
Obtain and respond to QA review
Participate in establishing standard quality and validation practices
Independently assess compliance practices and recommend corrective actions
Approve validated computer system related change requests
Monitor regulatory and inspection trends and advise the business on suitable action
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Ability to create documents to an existing document standard
Working knowledge of Documentum
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members
Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries
Experience in producing software documentation and business requirement documentation (minimum 3 years); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Michelle:

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