Senior Validation Specialist

2 days ago

Kottayam, Kerala, India beBeeSystem Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

About People Prime Worldwide has been removed for the new company job description

We are a technology company that provides information technology, consulting and business process services.

Our expertise includes cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics and other technologies.

Key Responsibilities:

  • Ensure compliance with GxP systems and regulations such as cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11 and ISO 9001 Standards.
  • Develop clear and concise reports on project progress and validation activities.
  • Work collaboratively with cross-functional teams to manage multiple projects and meet deadlines.

Requirements:

  • 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.
  • Experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.

Preferred Qualifications:

  • Ability to handle multiple projects and meet deadlines.

This role offers an opportunity to work in a dynamic team environment and develop your skills in Computer System Validation and Quality Compliance.

The ideal candidate will have a strong background in Computer System Validation/Quality Compliance and excellent communication skills.

We strive to create a collaborative and inclusive workplace culture and look forward to hearing from you.

This job description is not designed to be comprehensive. We welcome applications from talented individuals who share our values and can contribute to our mission.

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