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Validation Specialist Jobs in Mumbai - PerkinElmer

Validation Specialist

PerkinElmer
experience-icon 0 to 3 Years
salary-icon Not disclosed
qualification-icon BCA, Any Graduate, Other Course
Expired

Posted: 17 Oct 20

Job Description

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
  • Scientific background preferred

Work Environment
  • Lab Environment (may need to follow Personal Protective Equipment and Safety Polices);
  • Office Environment.

Job Particulars

Education BCA, Any Graduate, Other Course
Who can apply Freshers and Experienced (0 to 3 Years )
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id1018682
Locality Address
Country India

About Company

PerkinElmer
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