Overview

GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Position Summary

GSK are looking for a Complaints Quality Coordinator to join the team at Barnard Castle. This person will be responsible for investigating complaints within a defined timescale and actioning any necessary remedial, corrective and preventive actions. They will also ensure that release products were manufactured and packaged in accordance with the licensing requirements and to promote quality/compliance.

Key Responsibilities

• Ensure that all complaints are recorded at the time they are received, that pertinent information (including samples) is gathered and investigated, and that reports are issued through established channels in a timely manner.
• Directing product complaints to product stream / support group complaint co-coordinators for investigation.
• Reporting outstanding complaints to product stream / function.
• Identify any associated adverse event (AE) / device incident (DI), and trigger investigation and reporting of these in accordance with Regulatory requirements and timelines.
• Involvement in Gembas (low level audits) in relation to complaint issues.
• Participate in internal audits of relevant production and support areas and manages action follow ups.
• Audit front for activity role.
• Priorities and provided an effective Product Release Service which ensures that all products released for sale or further processing have quality appropriate to their intended use, i.e. comply with company GMP standards and product quality specifications.
• Directs and inputs into investigative work where products fail to meet requisite standards and recommend rejection or rework as appropriate. Develop and agree corrective actions arising from such incidents.
• Approves procedures, completes protocols, method statements utilised within relevant areas of business. An awareness of relevant safety, COSHH, surveys and safe working practices in the area.
• Adherence to agreed service levels on document /batch reviews.
• Ensure that the Quality Manager and relevant Business unit management are notified of any deviations from GMP, which may have a significant effect on product quality.
• Provide GMP advice on an ongoing basis. Leads quality improvement activities
• Provide OQ representation on projects (as applicable)
• Prepare training materials and provide training within relevant area (as applicable)

 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.

Inclusion at GSK

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.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are aUS Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.