Looking for Validation Lead Location - Kalamazoo, MI

[Angel G]

Hi,

 

Good Day!

 

Kindly go through the below position and let me know your interest with updated resume

 

Position: Validation Lead

Location - Kalamazoo, MI
Rate : $60/hr

Client: CTS

ONLY Citizens and GC

Job Description:

Looking for a Validation Lead to demonstrate a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment or independently to meet defined objectives based on established timelines and deliver project work in a manner that is consistent with the company’s values. The activities would include:

• Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.
• Review of project deliverables on timely manner and bring regulatory risks, if any, to project team and track them to closure

Technical Responsibilities:
•         Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies
•         Review functional design specification, technical design specifications for clarity, Good documentation practices.
•         Review the accuracy and completeness of software validation deliverables created by process work streams
•         Knowledge of software testing. Ability to create Traceability Matrices linking approved requirements to test cases within HPALM.
•         Create validation deliverables like Requirements, Data Migration Plan, Summary Reports, work instruction documents for tools
•         Ability to pull necessary details from an object level Technical Design Specs and Functional Design specs  and consolidate the information in a Master Technical and Functional Design document that is presentable to an external regulatory agency.
•         Experience working in an agile environment is preferred
 
Relevant Years of Experience: 5 to 8 years

Must Have Technical Qualifications:
Working experience in Validation projects is must. Experience in writing Validation Plan, Validation Summary report and review of SDLC/project deliverables is must. Person should have very good knowledge of FDA regulations/GXP/21CFR Part 11

Must Have Business Qualifications:
•         Very good communication skill with strong customer relationship management skills
•         Proactive and Innovative.
•         Good analytical skills. Should be able to evaluate a situation and take right decisions.
•          Should be able to own the activities and drive for completion.
Capabilities to host meetings, capability of handling multiple projects, multiple stakeholders and Conflict resolution.

Nice to Have Qualifications:
 Working experience in SAP validation experience and working experience with validations tools like HPALM and Solution Manager 

Thanks & Regards,

 

Angel G – IT Recruiter

American IT Resource Group, Inc.

1111, Plaza Dr., Suite 640, Schaumburg, IL - 60173

Desk: 312-585-7011;

Email: an...@aitrg.com