Corporate Compliance Specialist

4 weeks ago

Montreal, Quebec, Canada Pharmascience Full time

The Corporate Compliance Specialist will support the corporate compliance department's operational performance, ensuring objectives are met and regulatory compliance is maintained. Responsibilities include managing quality agreements, managing change controls, SAP status of suppliers, customers, and service providers, supporting international product compliance activities, and handling compliance documentation for pharmaceutical licenses.

Responsibilities & Duties:

  • Evaluate corporate change controls, assign actions, and close assigned actions.
  • Monitor the status and closure of assigned change control actions within the corporate quality & compliance department.
  • Provide support if necessary for a timely execution of assigned actions.
  • Creation and maintenance of a customer/vendor database to monitor GMP/GDP compliance status. Support quality initiatives such as supplier qualification and approval.
  • Approve in SAP subcontractors, customers, and suppliers from a GMP & GDP perspective.
  • Verify the GMP compliance of all parties in the supply chain and that all sources are in accordance with the relevant marketing authorizations.
  • Act as a liaison with external bodies/partners/clients, as required, to ensure appropriate compliance guidance. Develop and strengthen relationships with the business units in the assigned territory.
  • Support international escalation cases and recall processes and support all communication with international authorities and customers.
  • Responsible for monitoring the compliance environment, providing proactive advice and expertise to other groups on a global basis and developing effective compliance strategies for assigned projects in line with corporate objectives.
  • Administrate PMS establishment licenses according to business evolution (in coordination with corporate auditors). Coordinate activities with Health Canada and foreign sites to obtain the required documentation and add or maintain the sites on the designated license.
  • Support customer quality complaints management and recall notifications for international operations. Support quality agreements with various concerned partners.
  • Support the recall process in accordance with Canadian POL-0016 (Health Product Recall/Recall Policy), GUI-0039 (Drug and Natural Health Products Recall Guide), SOR/08-282 (Medical Devices Regulation), GUI-0054 (Guide to Recall of Medical Devices), 21 CFR 7.40 to 7.55, and all other applicable regulations.
  • Support the release of products internationally by reviewing CMC documentation (executed files, deviations, change control, investigations, etc.) in accordance with international regulations and product marketing authorizations.
  • May conduct external audits according to the established audit schedule. Perform follow-ups on audit observations and responses (suppliers).
  • Qualify subcontractors, customers, and suppliers from a GMP & GDP perspective. Approve any subcontracted activities that may impact GMP & GDP regulations.

Skills, Knowledge & Abilities:

  • Knowledge of local & international regulatory requirements and quality management standards & systems.
  • Strong understanding of international regulatory processes for generic pharmaceutical products.
  • Excellent knowledge of Good Manufacturing Practices.
  • Good knowledge of dosage forms (solid, semi-solid, liquid) and manufacturing & packaging processes.
  • Strong organizational, analytical, and communication skills.
  • Excellent command of French & English language, both verbal and written.
  • Experience in working with a multicultural environment will be considered an advantage.
  • Precision in execution of work with attention to detail.
  • Strong ability to follow detailed processes and procedures.
  • Ability to work in a team environment.
  • Results orientation and efficiency driven.
  • Multitasking ability.
  • Experience working with suppliers and contract manufacturing/testing organizations.
  • Excellent knowledge of SAP, TrackWise.

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