Sr. QA Executive

3 hours ago

Chennai, India Athenese Dx Private Limited Full time

Summary: The Sr. QA Executive is responsible for supporting various aspects of quality management, including document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management. Responsibilities also include assisting with change control, supplier evaluation, risk management, product and process validation, complaint handling, CAPA support, and quality improvement projects, Involve data entry, analysis, and report preparation to ensure alignment with quality and compliance objectives


Job Responsibilities:


  1. Document Control: Assist in maintaining and organizing quality documentation, including Quality Manual, Documented Procedures, Standard Operating Procedures (SOPs), and forms.
  2. Internal Audits: Participate in internal audits of various departments to assess compliance with the Quality Management System (QMS) and report findings to senior QA staff.
  3. Non-Conformance Management: Support the investigation of non-conformities or deviations, aiding in root cause analysis and the development of corrective and preventive actions (CAPAs).
  4. Change Control Support: Assist in the change control process, including reviewing change requests and assessing their potential impact on quality and compliance.
  5. Risk Management Assistance: Collaborate with senior QA staff in performing risk assessments and assisting in the implementation of risk management strategies.
  6. Product and Process Validation Support: Participate in product and process validation activities, ensuring that they meet specified requirements.
  7. Complaint Handling Support: Assist in the review and resolution of customer complaints related to product quality.
  8. Corrective and Preventive Action (CAPA) Support: Support CAPA processes by helping to gather data and track the progress of corrective actions.


Education and Experience

  • Bachelor’s / Master's degree in life science background.
  • 2 to 4 years of relevant experience preferred in a similar role in IVD industry.


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