Responsible for ensuring the accuracy, completeness, validation and compliance of deliverables by plan/lead/review/train/guide/support of the validation packages of IT applications in a regulated industry.
Actively participate in the Validation Life Cycle of regulated IT projects by
Planning validation deliverables
Working on validation documentation
Authoring Validation Plan & Validation summary report
Review of User requirement specifications, functional requirement specifications and Design requirements specification
Creation of traceability matrix
Review of validation protocol development (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)) and Test Summary Reports.
Executed scripts reviews and deviation management
Working with cross-functional project teams to support validation activities
Provide guidance/feedback to IT project teams in Validation compliance as per the applicable regulator
Proficient in GAMP , 21 CFR Part 11, EUAnex11 and GDP.
Facilitates IQ working with Business Analyst, Development Team and Compliance Engineer
Facilitates OQ working with testing team, Business Analyst and Compliance Engineer
Facilitate PQ working with Business user community and Q&R. - Major Keywords
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Antal International by 2x