QA Sterility Assurance Manager

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 activities

Escalate appropriately to site leadership team and Global Quality Assurance issues / risks associated with Sterility and Environmental Monitoring

Maintain and ensure aseptic procedures are in place and in use

Advise on all aspects of aseptic production and qualification

Support investigations where aseptic assurance is at risk

Oversight of microbial control strategy

Establish and monitor Sterility Assurance and EM Key Performance Indicators

Perform 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 performed

Review and approve documents connected with Sterility Assurance topics

Basic Qualifications & Skills :

University degree in scientific orientation, preferably in microbiology or related fields

Minimum 5 years experience in the Pharmaceutical industry

Native Hungarian with fluent English skills

Good knowledge and expertise of aseptic processes, sterile manufacturing

Preferred Qualifications & Skills :

People management experience

Good interpersonal, communication (including presentation)and influencing skills

Analytical thinking / Conceptual thinking

Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks

Creative approach to problem solving.

Clear leadership capability / potential

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 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.

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