System Validation Expert

1 week ago

Dindigul, Tamil Nadu, India beBeeSystemValidation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description

We are seeking an experienced System Validation Expert to join our team.

The ideal candidate will have a strong background in computer system validation, quality compliance, and FDA regulated industries.

About the Role:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in EDMS & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
  • Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

Responsibilities:

  1. Develop and implement effective system validation strategies.
  2. Conduct thorough risk assessments and gap analyses.
  3. Maintain accurate records and documentation.
  4. Collaborate with cross-functional teams to ensure compliance.
  5. Stay up-to-date with regulatory requirements and industry best practices.

Requirements:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
  • Strong knowledge of FDA Regulated manufacturing processes and GMPs.
  • Hands-on experience in EDMS & Test Management tools.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.

How to Apply:

  • Please submit your resume and cover letter.

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