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External Supply QA Specialist

2 months ago

Halifax, Nova Scotia, Canada 9605 GSK Services Sp z o.o. Full time
Job Title: External Supply QA Specialist

GSK is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can thrive.

Job Summary:

This role supports the Quality relationship with assigned External CMOs/Suppliers in External Supply specific region to ensure GSK's product quality, compliance, and reputation are protected. The successful candidate will establish and maintain an effective working relationship with key contacts at the assigned CMOs/Suppliers.

Key Responsibilities:
  1. Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external CMOs/suppliers are met.
  2. 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.
  3. As required, report to Quality Council, Local Incident Committee & Product Incident Review Committee (LIC, PIRC).
  4. 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.
  5. Provide specific GMP training for contractors, where deemed necessary.
  6. Manage CMO/supplier change controls, deviations, and customer complaints as required within GSK systems.
  7. Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure.
  8. Ensure timely communication of Quality Alert issues. Coordinate and track any continuous improvement.
  9. Build & maintain good working relationships with internal partners, through compliance with applicable 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.
Benefits:
  • 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.