Job Description :
Title : Validation Analyst/Lead
Location: Princeton, NJ/ PA/ MA
Position Type: Contract
Job Description:
1. : Validation Lead- Princeton, NJ (Remote Start )
· Minimum 6-8 years of hands on experience in Computer System Validation as a Validation Analyst/Lead
· Independently lead the validation activities
· Author, review and approve Validation Plan (VP) and Validation Summary Report (VSR) for the project.
· Review user and functional requirements (URS and FRS) for ambiguity, completeness and correctness.
· Define test strategy as per GAMP5 risk based testing (functional risk assessment)
· Review and approve IQ, OQ and PQ for test coverage and test mapping (RTM
· Ability to manage and assign work of 1-2 Validation Analysts.
· Ability to understand and enforce compliance to client’s CSV SOPs.
· Ability to schedule and lead meetings, moderate decisions and negotiations.
· Ability to course correct, develop next steps and define path forward in strategic/tactical situations within project life-cycle.
2 Life Science Compliance Specialist- Princeton, NJ (Remote Start , until Covid situation changes)
Requirement:
Minimum of 10 years of compliance experience within the Life Sciences industry and regulated environments (GMP, GCP, GLP)
Professional experience in regulatory validation requirements, including CSV, 21 CFR Part 11 compliance, EU Annex 11, and the GAMP-V model
Roles and Responsibilities:
Perform project review of validation deliverables in-line with SDLC methodologies and required SOPs
Change request review and approval
Facilitate regulatory assessments/checklists and ensure that CMDB information is aligned with the same
Perform IT vendor assessments
Conduct IT computer system periodic reviews
IT Failure Investigation and CAPA reviews and approvals
Review and approve IT Policies, Master Plans, SOPs and WPs and Application Use/Administration SOPs/WPs
Providing guidance on Good Documentation Practices
3. Role : Life Science Validation Specialist - Center Valley , PA or Boston , MA
Strong experience in Computer Systems Validation (CSV) for GxP applications, 21 CFR part 11/ GAMP5 risk-based validation
Should be highly skilled in Preparation of validation deliverables like Computer System Risk Assessment, Validation plan, Functional risk assessment, Traceability Matrix, Validation Final Report, Change Management, configuration management
Strong Stakeholder management, Test Management skills and Communication skills
SFDC/SAP, Case management Experience is an added advantage