Job Description :
Role : Validation Lead
Emp Type : Permanent Job
Interview : Phone/Skype
Location : Kalamazoo, MI
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 /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

Client : PDDN INC.