Posted:14 hours ago|
Platform:
Work from Office
Full Time
Advisory
Industry/Sector
Not Applicable
Specialism
Risk
Management Level
Senior Manager
& Summary
Responsibilities
Having 48 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)
Mandatory Skill sets
CSV
Preferred Skill sets
LIMS/QMS
Years of Experience required
48 years
Education qualification
B.Tech
Education
Degrees/Field of Study required Bachelor of Technology
Degrees/Field of Study preferred
Certifications (if blank, certifications not specified)
Required Skills
CSV
Optional Skills
Accepting Feedback, Accepting Feedback, Accounting and Ficial Reporting Standards, Active Listening, Analytical Thinking, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Coaching and Feedback, Communication, Compliance Auditing, Corporate Goverce, Creativity, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Embracing Change, Emotional Regulation, Empathy, Ficial Accounting
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