Quality Assurance Specialist - Sanofi - Budapest

At Sanofi CHC, we have one shared mission– we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. Everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are on an exciting journey as we have created a fully standalone CHC Business Unit (separating the Business Unit from our Pharma company heritage and processes), to create an agile, consumer-centric and responsive organization to deliver our ambition: to become the best Fast Moving Consumer Health (FMCH) company in and for the world.

Quality Assurance Specialist

The Quality Assurance Specialist supports team leader, quality managers and regulatory managers to ensure compliant management of all CMOs and related products assigned to EM CHC, Quality and Compliance in line with current GMPs, GDPs, relevant regulatory requirements and internal Sanofi standards.

The QAS acts as the process owner for assigned processes and as Key User for assigned Computerized Systems.

Document coordination in Veeva/CONNECT (CMS): (Re)versioning and archiving of documents in consultation with the Quality/Regulatory Manager and the respective contact persons of the contract manufacturers as well as in coordination with Regulatory Affairs, if applicable.

Support to Quality Manager with quality related change control requests, product quality review, creation of events and CAPAs.

Duties

• Creation and maintenance of CONNECT QTP records:
• Maintenance of attribute fields, APIs, excipients, primary packaging materials for assigned products
• QSMP statements for assigned products
• Maintenance of quality assurance agreements / annexes and other relevant documents
• Creation of queries from databases (e.g. VeevaVault DM / RT, CONNECT) in cooperation with team leader, Quality/Regulatory Manager
• Maintenance of product list for assigned products
• Creator or document manager in CMS CONNECT like e.g. archiving of PQRs, GAP assessments
• Support of master data check for new GMIDs
• Key user, super user etc. for assigned computerized systems and SME for assigned processes
• Support of audits and inspections

• Background and Experience

• Degree in natural sciences, engineering, technical services
• several years 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
• Analytical and structured way of thinking, communication skills, sense of responsibility, self-confidence, decisiveness, self-reliance
• At least 3 years of expertise in quality

When joining our team, you will experience:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An attractive, market-oriented salary and cafeteria benefits
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
• Work from an "Office of the Year 2020" finalist office
• Collective life and accident insurance
• Yearly medical check-up
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Your own career path within Sanofi. Your professional and personal development will be supported purposefully
• Practice your language skills within our "Language Club"
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

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 

#LI-CHC

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 or gender identity.

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