External Supply Quality Assurance Specialist

3 weeks ago

Halifax, Nova Scotia, Canada 9605 GSK Services Sp z o.o. Full time

About the Role

This position supports the Quality relationship with assigned External Contract Manufacturing Organizations (CMOs) / Suppliers in External Supply specific region to ensure GSK's product quality, compliance, and reputation is protected.

Key Responsibilities:

  • Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure Good Manufacturing Practice (GMP) expectations for GSK external CMOs/suppliers are met.
  • Support collection, monitoring, and analysis of quality performance indicators of the external CMOs/Suppliers using quality standards and tools in place to identify/escalate/emerging/developing trends and where appropriate use risk management tools to escalate and track significant risks requiring resolution.
  • As required, report to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC).
  • Liaise with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, change controls, validation activities, annual product reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance.
  • Provide specific GMP training for contractors, where deemed necessary.
  • Manage CMO/supplier change controls, deviations, and customer complaints as required within GSK systems.
  • Work with External Suppliers to establish effective Corrective Action and Preventive Action (CAPA) plans, in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure.
  • Ensure timely communication of Quality Alert issues. Coordinate and track any continuous improvement.
  • Build and maintain good working relationships with internal partners, through compliance with applicable Standard Operating Procedures (SOPs), Technical Terms of Supply, and Service Level Agreements as applicable.

Requirements:

  • 1+ year experience in various Technical, Regulatory, or Quality Assurance roles with an understanding of quality systems and quality control processes.
  • Developing knowledge of quality system principles and practical applications.
  • Demonstrated ability to make grade-level decisions based on facts and data and application of risk management principles.
  • Fluent English.
  • Developing presentation skills.

What We Offer:

  • Career at one of the leading global healthcare companies.
  • Contract of employment.
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
  • Life insurance and pension plan.
  • Private medical package with additional preventive healthcare services for employees and their eligible dependents.
  • Sports cards (Multisport).
  • Possibilities of development within the role and company's structure.
  • Personalized learning approach.
  • Extensive support of work-life balance.
  • Supportive community and integration events.
  • Modern office with creative rooms, fresh fruits every day.
  • Free car and bike parking, locker rooms, and showers.

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