Senior Quality Assurance Specialist

8 hours ago

Anand, Gujarat, India beBeeValidation Full time ₹ 22,94,400 - ₹ 26,11,200

Join Our Team as a Quality Assurance Specialist

Our company is seeking an experienced Validation Engineer to join our team. In this role, you will be responsible for ensuring the quality and integrity of our products.

As a Validation Engineer, you will work closely with cross-functional teams to develop and implement validation protocols, inspect equipment, and ensure compliance with regulatory requirements.

Required Skills and Qualifications:
  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of 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.
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • 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.
Benefits:
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • A dynamic and supportive work environment.

The ideal candidate will have a strong passion for quality assurance and a desire to make a meaningful contribution to our team.

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