Senior Quality Assurance Specialist

4 weeks ago


Thiruvananthapuram, Kerala, India SecureGen Full time

SecureGen is seeking a Senior Quality Assurance Specialist to provide quality and compliance oversight for GxP computerized systems across SecureGen internal and pharma clients hosted implementations. In this role, you will be responsible for ensuring that GxP systems are validated in compliance with current regulations and SecureGen's risk-based computer system validation procedures. Key responsibilities include:

  • Leading all quality initiatives for both internal and client-hosted computer system implementations as a Computer System Validation Domain Process Owner
  • Driving strategy and direction of the development of standards and procedures and aligning with key partners on implementation of validation requirements
  • Providing guidance on and interpretation of GxP guidance and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements (21 CFR Part 11, EU Annex 11)
  • Providing computer system validation quality assurance oversight for computerized systems used in Drug Development clinical functional areas, including Data Sciences, Biomarkers, and Clinical Pharmacology
  • Providing guidance for the implementation and validation of computerized systems, including the review and approval of validation deliverables and change controls
  • Supervising quality initiatives, including fostering a commitment to Quality in individuals and a culture of quality within SecureGen

Requirements:

  • Bachelor's degree with 5+ years of experience with implementing and validating regulated clinical systems
  • Extensive understanding of GAMP 5, SDLC, ICH guidelines, 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems, including good documentation practices
  • Exceptional verbal, written, interpersonal, organizational, and project management skills
  • Excellent organizational and project management skills
  • Able to lead and mentor junior/senior staff and cross-functional teams


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