Senior System Validator

2 days ago

Allahabad, Uttar Pradesh, India beBeeValidator Full time ₹ 15,00,000 - ₹ 25,00,000

About People Prime Worldwide:

We are a leading software giant with over 11.3 billion dollars in revenue, a global workforce of 240,000 employees, and presence in 60+ countries.

Our team is seeking a skilled Validation Engineer to join our ranks.

Key Responsibilities:

  • Develop and maintain computer system validation plans and reports
  • Conduct risk assessments and audits to ensure compliance with FDA regulations
  • Collaborate with cross-functional teams to identify and implement process improvements
  • Communicate complex technical information to both technical and non-technical stakeholders

Requirements:

  • Bachelor's degree in a related field or equivalent
  • 5-8 years of experience in computer system validation and quality compliance in a FDA-regulated industry
  • Strong knowledge of cGMP concepts, FDA/EMA regulations, and ISO 9001 standards
  • Hands-on experience with EDMS and Test Management tools
  • Excellent written and oral communication skills

Preferred Skills:

  • Hands-on experience with Microsoft Office and Visio

This role requires an expert level understanding of software systems and business processes.

The ideal candidate will have hands-on experience with EDMS and Test Management tools, as well as excellent written and oral communication skills.

They should also be able to communicate complex technical information to both technical and non-technical stakeholders.

Additional responsibilities may include conducting risk assessments and audits to ensure compliance with FDA regulations.

A Bachelor's degree in a related field or equivalent is required for this role.

Additionally, the ideal candidate should have at least 5-8 years of experience in computer system validation and quality compliance in a FDA-regulated industry.

Finally, they should have strong knowledge of cGMP concepts, FDA/EMA regulations, and ISO 9001 standards.

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