Specialist, QA Validation data (1 year fixed-term contract)

Job title:

Specialist, QA Validation data (1 year fixed-term contract)

Company:

GlaxoSmithKline

Job description

This role is open for a 1 year fixed-term contractAbout the rolePerform quality oversight on equipment and computerized and automated / analytical systems used in QC Belgium. Being fully accountable for establishing and maintaining of validated state of the assigned QC equipment and computerized systems.About the responsibilities

• Contribute to the development/improvement of QC equipment and computer validation methodology and process to align with GSK requirements (review and approve SOPs, governance participation…). And support the development of new automated technologies from a quality perspective.
• Provide QA expertise to support to new equipment’s and/or computer system project and you act as a partner/stakeholder in projects (participation to steercos, management of external resources workload…).
• Write or review and approve the equipment validation documents (e.g. validation plan, user requirements, Technical Change Description…including Periodic review documents) as quality authority in accordance with procedures and timelines.
• Review and approve deliverable created as part of the validation of computerized systems and End User Application (e.g. validation plans, user requirements, test documentation….) as quality authority in accordance with procedures and timelines.
• Oversee that the QC data generated electronically (or hybrid process) is obtained, used, back-ups performed and archived in accordance with Data Integrity principles, GxP, and GSK requirements.
• Review and approve CAPA, deviations, change controls and SOPs related to the area of responsibility in accordance with procedure and timelines.
• Ensure the inspection readiness status for L2/L3/L4 audits related to the area of responsibility. Support QC in the audit’s preparation and present topics during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility.
• Promote a continuous improvement mindset in activities within the team, peers, and operational partners to ensure that the compliance level is maintained in line with cGMP and GSK standard requirements and that this compliance level is fit-for-purpose.
• Manage complex and critical technical problems, evaluate potential impact on product quality and timely escalate to management.
• Participate with rest of the team to quality oversights on the shopfloor and internal audits in accordance with the QA oversights/L1 audit planning. And You ensure the compliance on EHS topics and develop the EHS mindset within peers and operational partners.

About you

• University Degree in Science (Chemistry, Biology, biochemistry, Bioengineer or Pharmacy) or equivalent by experience
• Minimum 3-6 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent V Cycle, GAMP 5, Validation methodologies and related documentation.
• At least 2-4 years’ experience in validation: fundamental steps of
• Good knowledge of international standards (CFR and Eudralex), GXP expectations. Good knowledge of inspection process. Previous participations to regulatory inspections
• Knowledge and expertise of quality systems in a pharmaceutical environment, such as, Deviation, Documentation Management, Training, Change Control, CAPA
• Good Knowledge of English (written and spoken)
• High quality mindset and good Knowledge of GMP regulated environment
• Project management and risk management principles and tools.
• Very good communication skills
• Working autonomously, must be capable of leading specific initiatives and collaborating hand to hand with operational teams applying quality fit-for-purpose
• Open-minded: wants to extend her/his technical competencies and do not hesitate to go “on the field” to understand and find solutions
• Customer focused and flexible thinking.
• Ability to adapt, work under uncertainty and accommodate flexible work demands.

#LI-GSK#GSKVaccinesThis role is open for a 1 year contract (CDD)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.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.Important notice to Employment businesses/ AgenciesGSK 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.

Expected salary

Location

Wavre, Brabant Wallon

Job date

Wed, 14 Aug 2024 06:16:12 GMT

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