Specialist, QA

¾ You’ at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively Specialist, QA In this role you will Master the key QA activities related to production, QC, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility Ensure batches of the intermediate product related to the area of responsibility are released in a timely manner Ensure deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner Supervise a team of technicians, distributes their work and is responsible for their training and development plan Represent QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC Page 2 / 5 follow-up meetings, ICG project, …) Ensure critical topics are adequately escalated to higher management Act as QMS subject matter expert (SME) (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans) Be the preferred front line spokesperson during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility Lead local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements Perform internal and act as external supplier audits Understand technical/production complex problems and evaluates potential impact on product quality Assess quality review files and draws adequate conclusions Provide QA expertise support to new product introduction projects and related validations This job opportunity is a permanent contract not opened for relocation. Why you? Qualifications & Skills: Scientific university degree (Pharmacist, Engineer or equivalent Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent Very good knowledge of English Knowledge of GMP regulated environment Experience Minimum 3 to 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent *Li-GSK GSKTechTalent Why GSK?: Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust. GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries. For further information, please visit www.gsk.com. If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. 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. 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.