Validation Specialist jobs in Mumbai at PerkinElmer

Job Title: Validation Specialist (Pharmaceutical or Biotechnology domain experience must)

Location: Mumbai, India

Type of Assignment: Contract

Job Description

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 PerkinElmer’s 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

Bachelor’s 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