Product Compliance Specialist

6 months ago

Toronto, Canada Johnson & Johnson Full time

Johnson & Johnson is currently recruiting for a **Product Compliance Specialist ** This position will be located in Toronto, CA.

**Position Summary**:

- Preparation of documents for Establishment Licensing submissions.
- Ensure the quality functions with the Purchasing Controls process, including maintenance of the Approved Supplier List (ASL) and Approved Distributor List (ADL) are maintained.
- Ensure robust supplier and wholesaler quality agreements are implemented for required sites.
- Ensures deviations/non-conformances are investigated in a compliant manner and related corrective/preventive actions are in place.
- Ensure on going product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Annual Product Reviews (APRs), Annual Stability reports, Supplier Release Documentation and Executed Batch Reviews.
- 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 complaints are handled in compliant manner.
- Ensures the timely and compliant release of product to the Canadian Market.

**Key Responsibilities**:

- Perform Establishment Licensing process (i.e., reviewing annual requirements, obtaining necessary documentation from sites, preparing submissions, etc.) and direct communication with Health Canada foreign site unit on queries to Janssen Inc. Canada.
- Ensure the Purchasing Controls processes are effectively implemented and managed (e.g. supplier audits and monitoring).
- Ensure the ADL and ASL are kept up to date.
- Negotiate/implement supply site/wholesaler agreements ensuring company and Canadian regulatory requirements are met and implementation of Canadian GMP’s and MRA frameworks where appropriate (Ensure Canadian requirements have been appropriately incorporated into the site’s procedures).
- Assess APRs and Annual Stability Reports and negotiate with the manufacturing/testing sites to address deficiencies/issues.
- Identify, investigate and resolve non-conformances, corrective and preventive actions in collaboration with internal and external business partners with respect to product release issues. Actions include assessment of adequacy of the investigations and/or corrective/preventive actions planned or taken and the coordination of investigations across functional areas/suppliers.
- Initiate, assess, and perform tasks related to change controls applicable to Canadian products
- Build and maintain relationship with supply sites, wholesalers and key internal partners.
- Partner/collaborate with key internal and external business partners to establish priorities, develop and manage systems/processes to support product compliance activities (Product release, GMP checks, validation review, APRs/Stability, Confirmatory testing, Executed Batch records, Inventory management, unique identifier, retain sample program, re-packaging at 3 rd party operations).
- Support new product launches and product site transfers ensuring that all Master Records and release specifications/documentation meet Health Canada marketing authorizations.
- Perform self-inspections and support HC GMP/DEL/MDEL/Controlled Substances & Corporate audits.
- Coordinate external supplier/vendor audits conducted by third-party, maintain audit plan and related documents in Quality Event Management system, and assess to ensure GMP compliance of sites.
- Develop and revise Standard Operating Procedures and Work Instructions as required.
- Participate in other quality projects as required.
- 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.
- Assess all data related to product returns to ensure all requirements are met for return to stock or recommend rejection.
- Maintain predefined performance expectations.
- Receive and perform intake of product complaints (PQC, and combined AE/PQC) from any source into the Quality Complaint Handling System in accordance with current regulation and corporate procedures.
- Monitor complaints entered into the Quality Complaint Handling System to ensure all required outreach activities/task actions are completed. Follow-up with customers, as required.
- Ensure field samples are retrieved in a timely manner and complete timely follow-up of field sample return.
- Support other departmental activities/initiatives as needed.
- Alternate Qualified Person in Charge (AQPIC) of the Premises

**Qualifications**:
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