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Computer System Validation Professional

3 weeks ago

Vizag, Andhra Pradesh, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000

System Validation Specialist

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At our organization, we focus on delivering innovative solutions in the field of computer system validation and quality compliance.

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  • Our team has extensive expertise in FDA Regulated industries, with a focus on GxP systems.
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Key Skills:

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  • A minimum of 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.
  • In-depth knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong understanding 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.
  • Familiarity with FDA's recent guidance on transition of CSV to CSA.
  • 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. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
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Responsibilities:

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  • Ensure compliance with regulatory requirements such as FDA and EMA guidelines.
  • Develop and implement effective quality control measures.
  • Collaborate with cross-functional teams to achieve project goals.
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Requirements:

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  • Bachelor's degree in a relevant field.
  • A minimum of 5-10 years of experience in a similar role.