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Senior PM for Corporate Treasury -Capital Markets / Financial Regulatory Program / Liquidity or Credit Risk Reporting

Senior PM for Corporate Treasury -Capital Markets / Financial Regulatory Program / Liquidity or Credit Risk Reporting

VTekis Consulting LLPToronto, Ontario, Canada
1 day ago
Job type
  • Full-time
Job description

Job Description

Skills and Responsibilities :

  • 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 the 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 J&J 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.
  • Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance with 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.

Roles and Responsibilities :

  • Support the product returns process to ensure all requirements are met for return to stock or recommend rejection.
  • Maintain predefined performance expectations.
  • B.Sc. in life sciences (Pharmacy, Biology, Physiology, Chemistry, Microbiology, Biotechnology, Biochemistry or equivalent education / experience.
  • Awareness of Post NOC changes.
  • Understands principles of product change management and the impact on marketing authorization.
  • 2-3 years Pharmaceutical Quality Control / Quality Systems.
  • Understanding of pharmaceutical production processes i.e. manufacturing, packaging, and testing"

    • Regards,

    Mohammed Ilyas,

    PH - 229-264-4024 or Text - 229-469-1455 or You can share the updated resume at Mohammed@vtekis. com

    Additional Information

    All your information will be kept confidential according to EEO guidelines.