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