Senior Validation Specialist

3 days ago

Guntur, Andhra Pradesh, India beBeeValidationEngineer Full time ₹ 20,00,000 - ₹ 25,00,000

About us:

We are a leading software company with over 11.3 billion dollars revenue, a global workforce of 2,40,000 employees, and presence in 60+ countries. We deliver end-to-end technology, consulting, and business process services to clients across the globe.

Job Title: Validation Engineer

Location: Hyderabad/Bangalore

Experience: 5 - 10 years

Notice Period: Immediate - 30 days

Mandatory Skills:

Required skills and qualifications

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years hands-on 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 (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.

Responsibilities:

  • Develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
  • Work on complex projects with general direction and minimal guidance.
  • Handle multiple projects and meet deadlines.
  • Manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

Preferred Skills:

  • Hands-on experience with Microsoft word, Excel, PowerPoint & Visio.
  • Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

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