Validation Specialist
PerkinElmer
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:
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
- 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
- Scientific background preferred
- 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
Job Category BSc/BCA/BBM , Journalism
Locality Address
State Maharashtra
Country India
About Company
PerkinElmer
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