Quality Assurance Expert

3 days ago

Pune, Maharashtra, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000

Job Overview:

We are seeking a highly skilled Quality Assurance Specialist to join our Technology & Transformation team.

Key Responsibilities:

  • Support IT quality systems framework design and implementation
  • Manage reviews and assessments for IT quality
  • Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies
  • Conduct GxP business process reviews
  • Develop integrated GxP and IT compliance
  • Create standard operating procedures and guidelines
  • Perform GxP and IT compliance assessments
  • Define validation strategy for IT software and systems
  • Participate in the validation life cycle of regulated IT projects or platforms
  • Ensure 21 CFR Part 11 compliance for computerized systems
  • Provide user training on CSV and increase awareness about compliance
  • Identify and address gaps in various gap/risk assessments
  • Audit IT systems to ensure regulatory compliance

Requirements:

  • Experience in IT quality, regulatory, and compliance (IT-QRC)
  • Knowledge of FDA, MHRA, and other regulatory bodies' quality guidelines
  • Familiarity with GxP practices and GAMP5 guidelines
  • Experience with computer system validation of COTS products
  • Strong understanding and practical experience of 21 CFR Part 11 and other FDA GxP regulations
  • Excellent verbal and written communication skills

Qualifications:

  • Experience range: 2-8 years

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