Commercial Quality Product Release Associate Consultant (Pharma) – CONTRACT

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Commercial Quality Product Release Associate Consultant with HYBRID option in Toronto, Ontario, CANADA for a 12 months CONTRACT, to join one of our major pharmaceutical clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

The primary scope of this work is providing support for quality and compliance review of products for Canadian market release.

Role Summary: 

• Ensures the timely and compliant release of product to the Canadian Market.
• Ensure regulatory compliance of all JI products through maintaining compliant specifications/standards(RSSs) and manages change to those standards. This includes assessing impact on GMP quality requirements and regulatory filing (e.g. changes to test methods, manufacturing and packaging).
• Ensure ongoing product compliance to Canadian Regulations and Client Quality requirements through review and evaluation of Supplier Release Documentation and Executed Batch Reviews.
• Support investigations of deviations/non-conformances to ensure closure in a timely and compliant manner, and any related corrective/preventive actions are in place.
• Other departmental tasks as assigned.

Major Responsibilities: 

• Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to recommend product disposition (approve/reject).
• Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
• Authorize the release of inventory in the SAP system ensuring accurate quantities, material status, and expiration date.
• Build and maintain relationship with supply sites, wholesalers, and key internal partners.
• Partner/collaborate with key business partners to establish priorities, develop and manage systems/processes to support product compliance activities (Product release, Executed Batch records, Inventory management, unique identifier, retain sample program).
• Review of Confirmatory Testing protocols and reports.
• Revise Standard Operating Procedures and Work Instructions as required.
• Participate in other quality projects as required.
• Support the product returns process to ensure all requirements are met for return to stock or recommend rejection.
• Maintain predefined performance expectations.

Job Knowledge Requirements: 

Relevant knowledge and experience 

• B.Sc. in life sciences (Pharmacy, Biology, Physiology, Chemistry, Microbiology, Biotechnology, Biochemistry or equivalent education/experience. If non-Canadian degree, an equivalency to Canadian university education is required.
• Awareness of Post NOC changes.
• Understands principles of product change management and the impact on marketing authorization.
• 5+ years Pharmaceutical Quality Control/Quality Systems.
• Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing.

Core/Technical competency requirements: 

• Strong analytical thinking and knowledge of current Health Canada GMPs.
• Attention to accuracy and details, good communication (verbal and written) skills.
• Ability to take initiative and work independently.
• Ability to interpret GMPs and application of their intent within the business environment.
• Builds and fosters networks and relationships to ensure collaboration across all business partners.
• Balance customer needs and business demands to move the business forward.
• Demonstrated judgment in dealing with compliance risk.
• Promotes and leverages the contribution of people with diverse ideas, perspectives, and backgrounds.
• Understands principles of product change management and its impact on marketing authorization.
• Manage multiple priorities including owning and balancing project management in addition to daily work.
• Preferred knowledge in quality management systems (Trackwise, Salesforce, ETQ), Document Management Applications (Veeva), SAP, and Microsoft Office Applications.
• Effectively learns new technologies and business processes.

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. 

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act (“PIPEDA”) , personal information is collected under the authority of the Act and will only be used for candidate selection.

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