Quality Assurance Specialist

2 days ago

Askersund Municipality, Sweden TFS HealthScience Full time
About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.

The Quality Assurance Specialist is responsible for independently planning, conducting, and following up on GMP and other GxP audits in accordance with company procedures, applicable regulations, and international guidelines.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in GMP manufacturing and pharmaceutical development.

Key Responsibilities:

  • Prepare, conduct, and follow up on GMP focused audits including system, vendor, and process audits

  • Support manufacturing sites and internal teams in preparation for GMP inspections

  • Facilitate and support sponsor and regulatory audits related to GMP activities

  • Provide GMP quality assurance advice and guidance to internal and external stakeholders

  • Contribute to continuous improvement initiatives related to GMP quality systems

  • Act as trainer and subject matter expert within GMP related training initiatives

Qualifications:

  • University degree or equivalent relevant industry experience

  • In depth knowledge of GMP regulations and guidance

  • Experience within GMP environments such as manufacturing, quality assurance, or quality systems

  • Three to ten years of GMP auditing experience

  • Ability to work independently with strong organisational and problem solving skills

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

  • Information Assurance Specialist

    1 week ago

    Solna Municipality, Sweden Saab Full time

    Brinner du för IT säkerhet och är en kommunikativ och driven person som trivs i en dynamisk IT miljö?Saab Surveillance kommer ge dig en spännande och varierad miljö där vi tillsammans verkar för att skapa och införa säkra IT lösningar för att stötta vår produktutveckling. Du kommer att bidra till detta genom att delta i hela lösningsprocessen...

  • Senior Quality Engineer

    4 days ago

    Solna Municipality, Sweden VALNEVA Full time

    About Valneva We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine...

  • Senior Quality Engineer

    4 days ago

    Solna Municipality, Sweden Valneva Full time

    About ValnevaWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine...

  • QA specialist

    7 hours ago

    Solna Municipality, Sweden Randstad Sweden Full time

    Har du en problemlösande och utredande approach? Tycker du om att ta beslut och därmed bidra till att läkemedel och medicintekniska produkter håller rätt kvalité och uppfyller ställda krav? Då är en roll inom QA rätt för dig Det innebär ett självständigt arbete, breda arbetsuppgifter och stor möjlighet till utveckling och eget lärande. Rollen...

  • Internal Control Specialist

    2 days ago

    Sundbyberg Municipality, Sweden Swedbank Full time

    We are looking for talent. Do you have what it takes?In Group Finance Process & Risk Control, we manage a bank-wide risk framework on Internal Control over Financial Reporting (ICFR). We add value by providing assurance on the reliability of Swedbank's quarterly statements. ICFR requires a combination of skills in Finance and Risk Management, as well as a...

  • Internal Control Specialist

    2 days ago

    Sundbyberg Municipality, Sweden Swedbank Full time

    We are looking for talent. Do you have what it takes?In Group Finance Process & Risk Control, we manage a bank-wide risk framework on Internal Control over Financial Reporting (ICFR). We add value by providing assurance on the reliability of Swedbank's quarterly statements. ICFR requires a combination of skills in Finance and Risk Management, as well as a...

  • people administration specialist

    4 days ago

    Solna Municipality, Sweden SAS Group Full time

    People / HR Administrator Become a part of our People Services Administration Team SAS is on an exciting journey of change and in a digital transformation within the People organization. We have come a long way but want to continue to create efficient processes and smooth administrative work.    Challenges you will work on: Provide administrative...

  • people administration specialist

    4 days ago

    Solna Municipality, Sweden SAS - Scandinavian Airlines Full time

    People / HR AdministratorBecome a part of our People Services Administration TeamSAS is on an exciting journey of change and in a digital transformation within the People organization. We have come a long way but want to continue to create efficient processes and smooth administrative work.Challenges You Will Work OnProvide administrative support across the...

  • people administration specialist

    4 days ago

    Solna Municipality, Sweden Scandinavian Airlines System (SAS) Full time

    City: SolnaJob Function: Human ResourcesPeople / HR AdministratorBecome a part of our People Services Administration TeamSAS is on an exciting journey of change and in a digital transformation within the People organization. We have come a long way but want to continue to create efficient processes and smooth administrative work.Challenges you will work...

  • Project Manager

    2 weeks ago

    Solna Municipality, Sweden Kintec Global Recruitment Full time

    Job Title: Senior Project ManagerLocation: Solna or Gothenburg, SwedenClient: Multinational Power CompanyAssignment Start: 1 st December 2025Assignment End: 31 st December 2026Assignment Type: ResidentialWork Schedule: 8 Hours per day / 5 days a week - (At least 3 days/week in the office. Wednesdays + 2 additional days)JOB DESCRIPTIONOur client is now...