Job Opportunity: Validation Consultant/ Lead : Noida

As a CSV (Computer System Validation) Consultant/ Lead your responsibilities includes developing validation plans, protocols, and test scripts; executing tests; performing risk assessments; documenting all processes; and ensuring that systems adhere to regulatory requirements throughout the lifecycle.

Required Skills and Qualifications

• Technical Skills:

  Proficiency with validation software (e.g., MS Project, ALM, Veeva Vault) and an understanding of manufacturing and supply chain applications.

• Regulatory Knowledge:

  Strong understanding of GxP, FDA regulations, and other relevant industry standards.

• Analytical and Problem-Solving Skills:

  Ability to assess systems for quality and compliance, analyze deviations, and provide logical solutions.

• Communication Skills:

  Excellent ability to communicate effectively with different teams and clients.

• Attention to Detail:

  Meticulous focus on accuracy, thoroughness, and ensuring all tasks and details are handled correctly.

• Education:

  Bachelor's degree in a technical field like Computer Science or Engineering, along with relevant experience.

Key Role and Responsibilities:

• Should have experience in CSV (Computer System Validation) in Life Sciences domain.
• Should have good knowledge of GxP regulations and GAMP 5 Guidelines.
• Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations.
• Should have experience in defining the validation strategy, approach, and alignment with customer on QMS.
• Should have good knowledge of Good Documentation Practices.
• Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice.
• Should have experience of Validating Safety Systems.
• Should have strong understanding of pharmacovigilance, regulations and guidelines for difference geographic location.
• Should have experience in reviewing the CSV deliverables such as IQ, OQ and PQ scripts.
• Experience of QA in FDA / EMEA regulated environment is preferred.

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