Quality Assurance Validation Specialist

1 week ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 5,00,000 - ₹ 8,00,000
Job Title

A highly experienced and skilled professional to lead the execution of complex validation assignments and ensure compliance with regulatory requirements.

This role is responsible for leading the execution of complex validation assignments and ensuring compliance with regulatory requirements. 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.

Responsibilities
  • Lead all phases of computerized systems qualification and validation. Review and approve validation packages, including requirement specifications, design specifications, test protocols, and validation summary reports, ensuring compliance with regulatory requirements and internal standards.
  • Serve as the primary QA contact for deviations and CAPA (corrective and preventive actions), ensuring proper investigation and timely resolution. Initiate and manage deviations as required and act as a quality reviewer for problem records.
  • Initiate, implement, and track the completion of change control requests related to computer systems. Review and approve periodic system reviews and audit trail reports to ensure system integrity.
  • Provide support for supplier evaluations and oversee GxP computerized systems programs and projects. Participate in and support regulatory inspections as required.
  • Apply strong analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data to develop effective solutions. Contribute to continuous improvement efforts and assist with training initiatives.
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.
  • Familiarity with tools and systems such as HP ALM, Jira, Confluence, and TrackWise.
Competencies
  • Leadership: Strong leadership skills with experience leading projects, teams, or tasks.
  • Problem-Solving: A demonstrated ability to handle and resolve complex quality issues using strong analytical and decision-making skills.
  • Autonomy: The capacity to work independently with minimal supervision and drive tasks to completion.
  • Collaboration: The ability to work closely with leadership and external experts to extend capabilities and enhance performance.

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