Senior Software Quality Assurance Engineer

2 weeks ago


Bengaluru, Karnataka, India bigtec Private Limited Full time
About the Role

We are seeking a highly skilled and detail-oriented individual to join our team as a Quality Control Engineer. The ideal candidate will have 3-5 years of experience in Computer System Validation (CSV), GAMP 5, GxP, and Quality Assurance for software development.

Key Responsibilities
  • Develop, maintain, and execute CSV protocols and reports in compliance with industry standards, including GAMP 5 and GxP.
  • Ensure validation documentation meets regulatory requirements and industry best practices.
  • Perform risk assessments and maintain validation documentation.
  • Work closely with software development teams to understand project requirements and design test cases accordingly.
  • Monitor and track software development processes to proactively identify potential quality issues.
  • Implement and maintain quality control measures throughout the SDLC.
  • Review and validate software documentation and deliverables.
  • Liaise with external agencies to implement GDPR compliance measures within the organization.
  • Act as a data manager, overseeing the collection, storage, and security of data in accordance with GDPR and other relevant regulations.
Requirements
  • Bachelor's degree / postgraduate degree in any discipline.
  • 2-4 years of relevant experience in software quality assurance, CSV, GAMP 5, GxP, and SDLC.
  • Strong analytical and problem-solving skills.
  • Excellent communication and teamwork skills.
  • Attention to detail and a commitment to delivering high-quality results.
Preferred Qualifications
  • ISTQB certification.
  • Knowledge of industry standards and regulatory requirements pertaining to software quality, validation, and data privacy (GDPR).
  • Experience with quality management systems.
  • Understanding of data protection principles and practices.
  • Experience in regulated industries.


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