What are the responsibilities and job description for the Software Validation Lead position at InfoQuest Consulting Group Inc.?
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Duration & Type : 12 months Contract with a major pharmaceutical industry client
Location : Princeton, New Jersey
Please Note : This is a W-2 only position.
Responsibilities :
- Responsible for managing higher level, complex GMP validation project activities from concept through process validation as per Validation Master Plan (VMP) and Corporate Policies and Procedures
- Define Validation Master Plan, Validation Strategy and coordinate with various stakeholders for IQ, OQ and PQ
- Plan, own and manage end to end Validation activities for enterprise level system implementations and relevant upgrades
- Manage and own validation testing including leading and defining GxP Testing Strategy
- Provide oversight and document review for validation projects and routine Validation Maintenance deliverables
- Perform Risk Analysis, Quality Planning, Deliverable life cycle Management as well as be the focal point of all validation management activities for the assigned project
- Educate different groups on GxP processes during project execution including alignment with SOPs and the processes to be followed
- Work on Testing strategy with co-located / remote teams and follow STLC lifecycle to ensure testing is completed as per processes
- Coordinate with Quality Control / CSQA to ensure adherence to corporate and regulatory standards
- Coordinate with relevant stakeholders to ensure adherence to and implementation of Change management methodologies
- Be the primary SPOC for giving directions to external vendors on adhering to corporate quality standards
Required :
For consideration, please send resume to career@infoquestgroup.com
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