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Quality System Specialist

date posted 05/14/2024
contract type Full time
job id R2744386
location Budapest, Hungary

Quality System Specialist - Sanofi CHC - Budapest

Our Business and Team:

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”. We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast Moving Consumer Healthcare (FMCH) Company In & For the World”. Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu. To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

In EM CHC EULA we are focused on the achievement of the Excellence that is under leadership of the diverse team.

The position holder supports team leader, quality responsible and regulatory responsible to ensure compliant management of all CMOs and related products assigned to EM CHC EULA in line with current GMPs, GDPs, relevant regulatory requirements and internal Sanofi standards.

He/she acts as process owner for assigned processes and as Key User for assigned Computerized Systems.

Important internal and external relations: CHC External Manufacturing Quality Assurance, CHC External Manufacturing Quality System, Global Quality External Manufacturing, Global Manufacturing & Supply, Supply Chain Managers, Quality System Excellence, Contract Manufacturing Organizations, Distributions Centers.

Main responsibilities:

The position holder is a contributor to ensure Quality Oversight (Quality Performance Review/KPI Reporting/Trending) and responsible for defined tasks within the Quality Systems Documentation (incl. SOP Management) and Training.

He/She is acting as Key User / first level support for quality related IT System Tools in use at EM CHC Europe and providing support to other teams within EM CHC Europe for defined topics.

- Contribute to the Quality Performance Review and KPI Reporting processes:

•          Assess and calculate KPIs and further data

•          Prepare reports and presentations

•          Enter data in IT tools, databases and tracking lists/dashboards

- Contribute to the documentation management process:

•          Support archiving process

•          Act as document management support for the teams within EM CHC Europe

- Contribute to the documentation and SOP management process:

•          First level process support for SOP authors

•          Monitor SOP management process

- Contribute to the training process:

•          Monitor and support

•          Contribute actively to the roll-out/deployment of an electronic learning management system and manage trainings in this tool

- Contribute to compliant use of quality related IT System Tools

•          Contribute to roll-out / deployment of IT System Tools.

•          Act as Key User / first level support within EM CHC Europe.

- Ensure that all activities in the area of responsibility comply with the relevant SOPs and contribute to continuous improvement.

- Support other teams within EM CHC Europe with tasks related to documentation, data management and creation of Events, CAPAs and internal Change Requests as agreed within the EM CHC Europe leadership level.

- Support of presentation of the Quality Systems in the area of responsibility in inspections and audits

About you

  • Experience in pharmaceutical environment, preferably in quality, i.e. quality control/assurance, systems quality assurance and/or quality systems management
  • Knowledge of pharmaceutical regulations/GMP
  • Good knowledge for computerized systems e.g. MS office package
  • Soft skills:
  • Ability to work in the diverse team (several locations)
  • Communication skills
  • Analytical and structured way of thinking
  • Being proactive
  • Teamwork
  • Sense of responsibility
  • Self-confidence
  • Rigor
  • Autonomy
  • Reactivity
  • Anticipation
  • Seeking efficiency and results
  • Commit to customers
  • Cooperate transversally
  • Education: Degree in natural sciences, engineering, technical services
  • Languages: Good English language skills to effectively negotiate and communicate verbally and in writing

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

            #Sanofi #WeNeverSettle       

            #SanofiCareers

            #PursueProgress

#DiscoverExtraordinary

            #joinsanofi

            #careerswithpurpose

            #SBSBUDAPEST

            #LI-EUR 

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

            #Sanofi #WeNeverSettle       

            #SanofiCareers

            #PursueProgress

#DiscoverExtraordinary

            #joinsanofi

            #careerswithpurpose

            #SBSBUDAPEST

#LI-CHC

            #LI-EUR 

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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