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IT Quality Specialist

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Hyderabad Secunderabad Telangana, India beBeeAssurance Full time ₹ 1,04,000 - ₹ 1,30,878

We are seeking a skilled Quality Assurance Manager to lead the execution of complex validation assignments and ensure the compliance of our systems. The ideal candidate will have extensive experience in Software and Systems Quality Assurance, a strong understanding of GxP regulations, and proven expertise in validation methodologies.

Key Responsibilities:
  • Lead all phases of computerized systems qualification and validation, reviewing and approving validation packages, including Requirement Specifications, Design Specifications, Test Protocols, and Validation Summary Reports.
  • Serve as the primary QA contact for deviations and CAPA (Corrective and Preventive Actions), ensuring proper investigation and timely resolution.
  • Initiate, implement, and track the completion of Change Control requests related to computer systems, reviewing and approving periodic system reviews and audit trail reports to ensure system integrity.
  • Provide support for supplier evaluations and oversee GxP Computerized Systems programs and projects, participating in and supporting regulatory inspections as required.
Required Skills and Qualifications:
  • A Master's degree with experience or a Bachelor's degree with extensive experience in Software and Systems Quality Assurance.
  • A strong understanding of regulations such as 21 CFR Part 11, EU Annex 11, and GAMP standards.
  • Proven experience in the validation of computerized systems and a strong application of GxP regulations (GMP, GLP, GCP, GPvP, GDP).
  • Experience managing quality assurance processes, including Change controls, Deviations, and CAPAs.
Benefits:
  • Opportunity to work on complex validation assignments and contribute to the compliance of our systems.
  • Chance to develop and apply strong analytical skills to evaluate complex problems and develop effective solutions.
About Us:

This is a high-profile role that requires a highly skilled professional with a deep understanding of GxP regulations and quality assurance principles.