Senior Quality Assurance Specialist

6 days ago


Montreal, Quebec, Canada Jubilant Pharma, LLC Full time
Job Summary

We are seeking a highly skilled and detail-oriented Senior Quality Assurance Specialist to join our team at Jubilant Radiopharma. In this role, you will be responsible for managing incident reports, investigations, and corrective and preventive actions (CAPAs) for sterile and non-sterile products.

Key Responsibilities:

  1. Participate in the investigation of incidents in collaboration with the relevant department manager or delegate.
  2. Prepare detailed investigation reports which are then submitted for approval by the Department Manager, Quality Assurance Manager. Carry out investigations on time to meet promised delivery deadlines.
  3. Work with department manager or delegate to determine corrective actions. Establish preventive actions based on root cause analysis results and prevent recurrence of similar incidents.
  4. Act as a resource person to other investigators and employees involved in the investigation process.
  5. Perform any other duties assigned by management.

Requirements:

  1. Bachelor's degree in science
  2. Three (3) to five (5) years' experience in the pharmaceutical industry
  3. Knowledge of aseptic processing, pharmaceutical processes and GMPs
  4. Manufacturing knowledge and problem-solving skills
  5. Excellent knowledge of investigation management, root cause identification and technical writing
  6. Knowledge of lean manufacturing principles (asset)
  7. Strong computer and software skills (MS Office)
  8. Excellence in written and verbal communication, with bilingual competencies in English and French.

About Jubilant Radiopharma:

Jubilant Radiopharma is a leading company in the radiopharmaceutical industry, dedicated to delivering high-quality products and services to patients worldwide. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development.



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