QA Expert

vor 1 Woche

Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site


Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own.

An exciting and challenging opportunity has become available at Takeda's Neuchatel Manufacturing plant (approx.

650 employees) for an experienced:

Quality Assurance Expert


Takeda's Neuchatel Quality department is looking for a highly motivated
QA Expert to join the team dedicated to providing quality oversight for operational activities related to purification manufacturing activities of biologic products.


This is an exciting career opportunity for a dynamic, autonomous, rigorous and change agile quality professional to embrace a team-based culture in a world-class Biotech manufacturing environment.


Your mission


As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight related to activities throughout the manufacturing and certification process.


The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities as well as for improvement initiatives for his/her department.

He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.

Participation in GMP zone audits as well as internal and external regulatory inspection is an integral part of his/her activities.

The QA expert is accountable for the promotion of continuous improvement and involved related initiatives.

Essential Duties & Responsibilities

  • Review batch records (paperbased and electronic format in MES system)
  • Contribute to the batch certification of products
  • Lead and/or review deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
  • Evaluate internal and/or external change requests and follow deployment through change control according to procedures, GMP requirements and regulatory licenses.
  • Prepare, evaluate, and approve controlled documentation revision
  • Participate and/or lead improvement initiatives and enhancement projects
  • Perform internal facility GMP audits of manufacturing and support areas
  • Participate in external regulatory agency inspections, observation responses and regulatory submission preparation as required
  • Participate in daytoday operational decisions as needed (including oncall service)
  • Report out of findings/issues to functional leaders and higher management as needed

Required Skills:

  • Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, Quality system standards and data integrity principles
  • Knowledge in auditing and inspection against regulatory / quality standards
  • Knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automation documentation, biotechnological processes)
  • Autonomous, structured, rigorous and selfmotivated
  • Solution oriented, pragmatic, ability to simplify complexity
  • Able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high quality standards
  • Team player, prepared to work in teambased culture including manufacturing personnel on the floor
  • Demonstrate excellent communication skills (oral and written), ability to adapt to audience
  • Excellent oral and written skills in English and French, fluency is an asset

Education & Experience

  • Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy or "Quality Management" applied to industrial process
  • 25 years of experience within a GMP environment, biotech/pharmaceutical company
  • Ideally demonstrated experience in Quality Assurance

Takeda's Outstanding Values
To help us achieve our mission, we believe in focusing on the needs of patients through empowering our teams.

Together, we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of
Takeda-ism: Integrity, Fairness, Honesty, and Perseverance.

Takeda-ism is more than just a word. It's a belief and a mindset which guides our decisions, behaviors, and interactions. It's how we strive to work and live, every day.

Locations:

CHE - Neuchatel

Worker Type:

Employee

**

  • QA Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    QA Expert - Drug Development ADAOur client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a QA Expert - Drug Development for 1 year contract with high possibility of extension based in Basel,...

  • QA Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    Takeda NeuchâtelSite de Production Biotech | Biotech Manufacturing SiteTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better...

  • QA Expert

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Expert Compliance

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Panda International Vollzeit

    QA Manager - CMO - Basel - Zurich:Location Basel, SwitzerlandBusiness Sector BiotechnologyJob ref 22212Published 11 days agoQuality Assurance Manager - SwitzerlandAre you an experienced QA professional in Biotech? Join our client in Northern Switzerland, a prominent leader in cell & gene therapy. As a Senior QA Manager, you'll play an important role in...

  • Technical QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ITech Consult Vollzeit

    Technical QA ManagerTechnical QA Manager (M/F/d) - GMP / Pharma / Qualification / Validation / CSVProjekt:For our client, a big pharmaceutical company in Basel we are looking for Technical QA Manager (M/F/d).Background:Tasks & Responsibilities: Running, maintaining and continuously improving Qualification/Validation activities including Computerized System...

  • Technical QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Technical QA Manager (m/f/d) - Quality Management / Qualification/Validation / CSV of Small Molecules / Data Integrity / GMP/IMP/ English & GermanProject: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical QA Manager (m/f/d).Background:The IMP Quality Operations Unit Switzerland in Global Technical...

  • Quality Assurance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Technical QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For a big pharmaceutical company in Basel we are looking for a Technical QA Manager Background:The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight...

  • Technical QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Technical QA ManagerYou will support the end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.You will be reponsible for running, maintaining and continuously improving...

  • Technical QA Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    Start date: As soon as possibleDuration: 1 year/possible extensionWorkload: 100%Location: Basel, on-site Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in BaseSupport of implementation of DI...

  • Technical QA Manager

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    Start date: As soon as possibleDuration: 1 year/possible extensionWorkload: 100%Location: Basel, on-site Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in BaseSupport of implementation of DI...

  • Technical QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    For our client from the pharmaceutical industry in Basel, we are looking for a technical QA managerGeneral Information:- start date: asap- extension: possible- workplace: Basel- remote: on-site required, home office upon discussion- travel: noTasks & Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment...

  • Technical QA Manager

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    General Information:start date: asapextension: possibleworkplace: Baselremote: on-site required, home office upon discussiontravel: no Tasks & Responsibilities:QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within PTD...

  • Quality Systems Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Quality Assurance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • QA Expert Compliance

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Audit Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Thermo Fisher Scientific Vollzeit

    As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • QA Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Mundipharma Vollzeit

    Support all Quality related activities in the Region Middle East & Africa and Europe Consumer Health. To carry out Quality Management system activities on behalf of IACS to ensure compliance to current GxP legislation Provide management, leadership and oversight of Quality Assurance activities for, third party contract manufacturers, packaging operations and...

  • Quality Assurance and Pharmacovigilance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    COMPANYALTOGEN is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.We surround ourselves with junior to expert level...