Shire Lead Quality Specialist in Toronto, Canada

Primary Duties

As a key member of Shire Canada QA department, contribute to ensure that Shire Canada is compliant with local GMP and GDP requirements for Medicinal Products (mainly Biologics) and Medical Devices. Contribute to prepare for, host and respond to External and Internal inspections.

  • Support the effective implementation of Shire Canada Quality Systems: own local SOPs, and work on CAPA, Deviations, Complaints and Change Controls. Also, execute QC, batch review and batch release activities as requested by the Shire Canada QA Manager.

  • Establish relationship and work collaboratively to resolve quality issues with Shire Contract Distributors (CDOs), Distributor partners, Contract laboratories and Customers. Participate to establish Internal and External Quality Agreement as directed by the Shire Canada QA Associate Director.

  • Provide Quality support to the local operation, for both the existing business and the new product launches. Act as a deputy for Shire Canada QA Associate Director.

  • Review and approve all data generated in accordance with current Canadian GMP Regulations.

  • Provide technical support globally to external suppliers in order to ensure Shire’s commercial products are manufactured in compliance of GMP.

  • Support and assist in coordinating Global Affiliates activities in compliance with local regulations and Shire Global Quality Manual.

  • Contribute to ensure that Shire Canada establishes and retains all applicable licences and permits required to import and distribute Shire products on the Canadian market.

Responsibilities

Contribute to ensure that Shire Canada establishes and retains all applicable licences and permits required to import and distribute Shire products on the Canadian market.

Contribute to prepare for, host and respond to GMP and GDP inspections for Medicinal products (mainly Biologics) and Medical Devices.

Keep abreast of trends and changes in the local Regulations for Medicinal products and Medical Devices. Contribute to provide an assessment of new applicable Regulations on the Canadian LOC, and execute the related CAPAs.

Act as a deputy for Shire Canada QA Associate Director.

Own local SOPs and execute quality activities such as Change Controls, CAPAs, Deviation Investigations, OOS, Mock recall, complaint, etc., as requested by Shire Canada QA Associate Director.

Manage temperature excursions and other Transport and Distribution deviations. Contribute to execute local Market Interventions, as requested by the Shire Canada QA Associate Director.

Provide Quality support to the local operation, for both the existing business and the new product launches.

Perform batch documentation review, confirmatory testing raw data review and related QA activities, and determine batch disposition as per Canadian Batch Release procedures. Liaise with BGTD and suppliers regarding any queries on batch certificate and documentation. Verify compliance with the marketing authorisation, e.g., CPID and Product Monograph.

Review Compliance documentation; Annual Stability Reports, Process Validation Documents, Annual Product Review Documents, Unique ID certification and Alternate Retention Sample Certification.

Work collaboratively with Distributor partners, review QTA and Quality review meetings as requested by the Shire Canada QA Associate Director. Handle returns, rejects, recalls or falsified products; oversee product rework; handle product destruction. Work to establish and change Internal and External Quality Agreement, as requested by the Shire Canada QA Associate Director.

Support GMP\GDP training program for Shire Canada personnel.

Maintain and further develop competence in GMP\GDP through regular training, benchmarking with colleagues, and coaching from Subject Matter Experts

Develop close relationship with other functions internally at the LOC site and with GSC e.g. Global Pharmaceutical Technology, Materials Management and Supplier Relationship Management.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.