Talent.com
This job offer is not available in your country.
Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

beBeeAuditAnand, Gujarat, India
2 days ago
Job description

Job Title : Quality Assurance Specialist

Job Description :

A quality assurance specialist plays a vital role in ensuring that all aspects of the quality management system adhere to regulatory standards and established guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.

  • Conducting audits : Perform internal and external audits to verify compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices (GDP), company standard operating procedures (SOPs), and other relevant regulations.
  • Quality management : Evaluate and maintain the quality management system (QMS). This includes reviewing quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs).
  • Documentation and reporting : Prepare detailed audit reports documenting findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with various teams to ensure issues are resolved.
  • Regulatory compliance : Stay up-to-date with all applicable regulations and guidelines from bodies like the FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory requirements are communicated and implemented across the organization.

Required Skills and Qualifications :

To be successful in this role, you should possess :

  • A bachelor's degree in a relevant field or equivalent audit experience.
  • Working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of Harmonisation (ICH), Electronic Records; Electronic Signatures (21 CFR part 11) and EU Annex 11, GDPR, or GAMP 5.
  • Strong analytical and problem-solving abilities for identifying discrepancies, evaluating data, and drawing logical conclusions from audit findings.
  • Meticulous attention to detail when reviewing documents, data, and processes.
  • Excellent written and verbal communication skills for clearly articulating audit findings and collaborating with diverse teams and stakeholders.
  • Thorough understanding of GCP, ICH guidelines, and other relevant clinical trial regulations.
  • Certifications from professional bodies can be advantageous.

    • About This Job :

    This job offers a unique opportunity to contribute to the success of our organization by ensuring the highest level of quality in our clinical trials. If you are a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply.

    Join our team of dedicated professionals who share your passion for quality and excellence. Together, let's make a difference in the lives of patients and communities around the world.

    Create a job alert for this search

    Quality Assurance Specialist • Anand, Gujarat, India