Senior System Validator

5 days ago

Mumbai, Maharashtra, India beBeeSystemValidator Full time ₹ 20,00,000 - ₹ 40,00,000
Job Opportunity

About Us:

We are a leading software giant with a global workforce of 240,000 employees and presence in over 60 countries. Our clients include top organizations across the globe.

Job Title: Validation Engineer

Location: Hyderabad/Bangalore

Experience: 5 - 10 years

Notice Period: Immediate - 30 days

Responsibilities

The ideal candidate will have hands-on experience in computer system validation/quality compliance in a FDA regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.

The candidate should possess strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.

Additionally, the candidate should be proficient in EDMS (Electronic Document Management system) & Test Management tools, and have understanding of FDA's recent guidance on transition of CSV to CSA.

The successful candidate will develop clear, concise, and timely oral and written reports, and demonstrate excellent written and oral communication skills.

Key Responsibilities:

  • Develop and implement quality control processes
  • Ensure compliance with regulatory requirements
  • Collaborate with cross-functional teams to achieve business objectives
  • Provide training and support to team members
Requirements

Required Skills and Qualifications:

  • Bachelor's degree (B.S.) in 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)

Preferred Skills and Experience:

  • 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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