Validation Specialist (BB-00D5B)

Found in: Talent IN

Roles and Responsibilities Design, Author, and Execute Computerized System Validation (CSV) according to GAMP 5 guidance especially on Analytical Laboratory Test Equipment and other Lab Information Systems Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents Translate technical information and requirements into qualification/validation test design Contribute to the overall growth of PerkinElmers compliance business Strong interpersonal skills and demonstrated ability work independently Organized and task oriented Excellent written and oral communication skills especially on technical topics Self-directed and motivated individual who can operate in a rapidly changing business environment Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project Ability to Build consensus among team of stakeholders Excellent critical thinking/analytical and problem-solving skills Experience with a multitude of laboratory equipment a plus Basic Qualifications Bachelors Degree 5-7 years of pharmaceutical of FDA related validation experience Good knowledge of GMPs, 21CFR Part 11, USP 1058 and other relevant industry regulations and guidance Preferred Qualifications Scientific background preferred Work Environment Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment.

calendar_today3 days ago


info full time

location_on Thane, India


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