System Assurance Specialist

3 days ago

Kanpur, Uttar Pradesh, India beBeeValidation Full time ₹ 12,15,000 - ₹ 18,18,000

Our client is a leading software company in India, with a global workforce and presence across the globe.

Job Title: Computer System Validation Engineer

Location: Bengaluru, Hyderabad

Experience: 5+ years

Job Type: Full Time Permanent

Notice Period: Immediate joiners

Client: MNC Client

Mandatory Skill:Computer System Validation,EDMS,Medical Domain

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) 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.

We are looking for an experienced Computer System Validation Engineer to join our team. The ideal candidate will have a strong understanding of FDA regulated manufacturing processes and quality compliance.

The successful candidate will be responsible for:

  • Validating computer systems and equipment to ensure compliance with regulatory requirements.
  • Developing and implementing quality control procedures.
  • Conducting audits and assessments to identify areas for improvement.
  • Collaborating with cross-functional teams to implement changes and improvements.

If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply.

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