External Supply QA Specialist

5 months ago

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



GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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 is protected. 
Additionally this role ensures the appropriate level of oversight with regards to CMO GMP activities in accordance with quality agreements by establishing and maintaining an effective working relationship with key contacts at the assigned CMOs / Supplier(s).

Key Responsibilities:

Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure 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 reporting 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 CAPAs, 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 & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreements as applicable.
 

Why you?

Basic qualifications:

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 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 everyday Free car and bike parking, locker rooms and showers.

#LI-GSK
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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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