QA Sterility Assurance Manager

GlaxoSmithKline

Job title:

QA Sterility Assurance Manager

Company:

GlaxoSmithKline

Job description

As our QA Sterility Assurance Manager, you will be the primary contact for sterility assurance, aseptic and bioburden controlled processes and environmental monitoring.Further responsibilities:Lead Sterility Assurance team, manage the work performance, define workload priorities, organize and control the activitiesBe the Single Point of Contact (SPOC) for any topic related to Sterility Assurance and Environmental MonitoringEscalate appropriately to site leadership team and Global Quality Assurance issues/risks associated with Sterility and Environmental MonitoringMaintain and ensure aseptic procedures are in place and in useAdvise on all aspects of aseptic production and qualificationSupport investigations where aseptic assurance is at riskOversight of microbial control strategyEstablish and monitor Sterility Assurance and EM Key Performance IndicatorsPerform internal audits against cGMP rules, company policies and procedures, and the authority regulations concerning Sterility Assurance topics.Ensure that trainings related to hygiene practices and aseptic practices are performedReview and approve documents connected with Sterility Assurance topicsBasic Qualifications & Skills:University degree in scientific orientation, preferably in microbiology or related fieldsMinimum 5 years experience in the Pharmaceutical industryNative Hungarian with fluent English skillsGood knowledge and expertise of aseptic processes, sterile manufacturingPreferred Qualifications & Skills:People management experienceGood interpersonal, communication (including presentation) and influencing skillsAnalytical thinking/Conceptual thinkingExcellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasksCreative approach to problem solving.Clear leadership capability/potentialWhy 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.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.Please note that if you are a US 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 the Centers for Medicare and Medicaid Services (CMS) website at

Expected salary

Location

Gödöllő, Pest

Job date

Sun, 15 Jun 2025 07:20:49 GMT

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