Spécialiste, Opérations Qualité /Specialist, Quality Operations

at  Jubilant DraxImage Inc

QUALIFICATIONS :

• B.Sc. en Chimie, ou Microbiologie, ou discipline étroitement liée
• Un minimum de trois (3) ans d’expérience dans l’assurance qualité, contrôle de la qualité, développement de production ou technique au sein de l’industrie pharmaceutique ou de soins de santé.

SPECIALIST, QUALITY OPERATIONS

Join our dynamic team at Jubilant Radiopharma as Specialist, Quality Operations! We are seeking a driven individual who thrives in a fast-paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations.

QUALIFICATIONS:

• B.Sc. in Chemistry, or Microbiology, or closely related discipline
• A minimum of three (3) years experience in quality assurance, quality control, production development or engineering within the pharmaceutical or healthcare industry

JOIN US:

If you are looking for a challenging yet rewarding opportunity to make a difference in the healthcare industry, we invite you to apply for the Specialist, Quality Operations position at Jubilant Radiopharma. Join us in our mission to deliver innovative solutions that enhance patient care and improve lives. Apply now and be part of our success story!
Job Overview

ROLE OVERVIEW:

Provide guidance and support to ensure our operations meet GMP requirements, JDI internal policies and regulatory agency standards. Accomplish this mission by (1) Assisting and supporting production operations in the detection and resolution of production issues in real time. (2) Participating in the resolution of quality issues and providing advice and practical solutions. (3) Providing GMP and regulatory support to the operations group to improve processes. (4) Performing assessment rounds; monitoring production operations and providing summary reports on results.

KEY RESPONSIBILITIES:

• Assist and support production operations in the detection and resolution of production problems in real time.
• Participate in the resolution of quality issues by providing advice and practical solutions.
• Carry out actual random checks during production operations.
• Perform assessment rounds, monitor production operations and provide summary reports on results.
• Perform and document in-process packaging verification for each batch produced.
• Act as primary quality point of contact when production problems arise.
• Monitor closure and effectiveness of CAPAs for production operations and issue monthly indicator reports.
• Support the Investigation Team by submitting relevant information on production incidents.
• Review and approve quality notifications related to minor production incidents. Ensure that the content of quality notifications comply with current GMP regulations and JDI policies and procedures.
• Advise on the accuracy of batch master records and report any required changes.
• Improve communication channels between departments.
• Perform other compliance tasks as required (internal audits, SOP review, complaint reports, audit preparation, etc.).
• Perform any other tasks assigned by management.