Imp Qualified Person

Vor 2 Tagen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
In this role you will act as Qualified Person (QP) in accordance with applicable regulations for Investigational Medicinal Products (IMPs) in the Pharmaceutical Science Quality Europe group of the global Pharmaceutical Science & Device Quality organization of Takeda.

**How you will contribute**:

- Perform QP certification activities with responsibility for Takeda IMPs in the fields of biologics, small molecules and plasma derived products in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations and the principles and guidelines of cGMP as laid down in Directive 2017/1572 and Delegated Regulation 2017/1569 and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products.
- Provide QA/QP support for work performed at, contract manufacturers and analytical laboratories, and coordinate priorities/workload with different key stakeholders to ensure the quality of investigational medicinal product and compliance with cGMP.
- Employ GMP QA expertise and principles during the development, manufacturing, testing, packaging and release of clinical trial material.
- Be responsible for the successful, timely completion of goals and objectives, which will strengthen the Takeda R&D Quality organization.
- Certify batches and finished products to be released by Takeda in the EC/EEA have been manufactured and checked in accordance with the CTA, GMP, Product Specification File and legal requirements as set out in Article 51 of directive 2001/83 and Article 61 of CTR 536/2014. to assure drug product, documentation, and data related to manufacturing, packaging, labelling, and testing of IMPs are compliant with all cGMP, SOP, CTA, and regulatory requirements.
- Batch documentation review and release activities per Takeda quality systems; (to be knowledgeable about the products supplied for clinical trials, to provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and regulatory requirements, to review and approve Master and Executed Batch Records and Packaging Labels, to ensure that all required batch documentation is obtained from contract manufacturer/suppliers to enable the release of product, to actively participate in project meetings as required)
- Effectively liaise with contractor manufacturers/suppliers regarding technical information and queries,
- Ensure that deviations and OOX (OOT, OOL,..) investigations are adequately investigated and documented and guarantee clinical complaints are adequately investigated and reported
- Review and approve analytical test methods protocols, Master Batch records, executed batch records, reports, specification documents, method qualifications/validations, and stability study plans/reports as they pertain to Clinical Trial Materials.
- Review regulatory submissions, drafting & coordinating Quality Agreements, documentation control
- Supporting the external auditing program, by participating in external audits as SME to assure compliance with GMPs, regulatory filings, FDA, EU and other applicable regulatory guidelines as well as building and maintaining strong working relationships with Clinical CMOs
- Maintain an up-to-date knowledge of the regulatory environment as it pertains to position and responsibilities.

**What you bring to Takeda**:

- Eligibility to act as Qualified Person in line with local and EU directives (QP certification of biological, Plasma derived and small molecule development products) and master’s degree in chemistry, biology, pharmacy or a related discipline
- At least 3 years experience working in an Quality Assurance role or in an Quality Assurance environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)
- Thorough understanding of quality systems and cGMPs
- Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
- QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with global GMP and regulatory requirements
- Be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs, IMPDs and clinical trial authorizations, evaluating of (trending) data
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Exchange and communication with the following internal stakeholders: Global and Local Quality Assurance, Global Clinical Supply Chain, Regulatory Affairs, Pharmaceutical Science, Pharmaceutical and Analytical Development, Quality Control, Process Development
- Exchange and communication with external stakeholders: Contract Manufacturers, Contract Distributors, Contract Laboratories
- Reading, understanding, speaking and writing in technical and legal English
- Ability to work during routine business hours bu

  • Qualified Person

    vor 7 Monaten

    Wien, Österreich STADA Arzneimittel AG Vollzeit

    Die STADA Arzneimittel AG kümmert sich weltweit als vertrauensvoller Partner um die Gesundheit der Menschen. Ursprünglich von Apothekern gegründet, sind wir einer der führenden Hersteller von hochwertigen Pharmazeutika. Mehr als 12.300 Mitarbeiterinnen und Mitarbeiter weltweit leben unsere Werte Integrität, Unternehmertum, Agilität und One STADA, um...

  • Qualified Person

    Vor 2 Tagen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: We are seaching for a Qualified Peron to strengthen our team. In this function you are responsible for the release of finished good to the market. This position offers a peerless chance - even for inexperienced QPs - gain experience within a global company with manifold product range! **How you will contribute**: - Release of finshed...

  • Qualified Person

    vor 1 Woche

    Wien, Österreich AOP Orphan Vollzeit

    **Professional Skills**: - Natural science/scientific background (FH, university) - Approval as Qualified Person according to - 2 Abs. 13b AMG or EU equivalent (article 48 of directive 2001/83/EC) - Min. 3-5 years’ experience in the pharmaceutical industry in the field of QM/QA, QC, production or CMC - Job experience as Qualified Person preferred -...

  • Qualified Person

    vor 7 Monaten

    Wien, Österreich globe personal services GmbH Vollzeit

    Unser Kunde ist ein international tätiger Pharmadienstleister mit Hauptstandort in Wien. Als zuverlässiger Partner für weltweit führende Pharma - und Biotechnologieunternehmen übernimmt das Unternehmen das gesamte Projektmanagement der Logistik und Bereitstellung von IMPs für internationale klinische Studien in Europa, den USA und Asien. Das...

  • Qualified Person

    vor 7 Monaten

    Wien, Österreich Talentor Sweden AB Vollzeit

    Unser Klient ist ein Top-Player am österreichischen Pharmamarkt dessen Portfolio bestens etabliert ist. Ab sofort wird eine engagierte und kommunikationsstarke Qualified Person gesucht: **Qualified Person (QP) / Sachkundige Person (w/m/x)**: **Voll - oder Teilzeit**: ***IHRE KÜNFTIGE ROLLE**: - Überwachung und Prüfung von Chargen gemäß den...

  • Qualified Person

    vor 7 Monaten

    Wien, Österreich globe personal services GmbH Vollzeit

    Globe personal services verbindet hochqualifizierte Fachkräfte sowie Experten mit ihren zukünftigen Arbeitgebern. Menschen und ihre Gesundheit stehen im Vordergrund für unseren Kunden. Um dies weiterhin gewährleisten zu können, benötigt das Pharma-Unternehmen Verstärkung im Bereich Quality. Daher wird zur Unterstützung am Standort Wien folgende...

  • Qualified Person

    vor 2 Monaten

    Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. **Responsibilities**: We are currently looking for a motivated** Qualified Person - QP (M/F/d) **to join our **Quality Assurance **Department in **Vienna**. Your Key responsibilities will involve...

  • Qualified Person

    vor 7 Monaten

    Wien 16. Bezirk (Ottakring), W, Österreich Kwizda Vollzeit

    **Kwizda Pharma GmbH**,** eine Tochtergesellschaft der Kwizda-Unternehmensgruppe, ist ein erfolgreiches und expandierendes österreichisches Arzneimittelunternehmen und leistet mit seinen Produkten einen wesentlichen Beitrag zur Erhaltung der Gesundheit und Lebensqualität. Dem hohen Anspruch an Qualität und Sicherheit der Arzneimittel trägt Kwizda Pharma...

  • Qualified Person

    Vor 6 Tagen

    Wien, Österreich GBA Group Vollzeit

    Zur Verstärkung unseres Teams aus dem Geschäftsbereich Quality in Wien suchen wir schnellstmöglich eine Qualified Person (QP) (m/w/d) (Unbefristet, Teil - oder Vollzeit, 30-40 Std./Woche) **Wir bieten Ihnen**: - Sie werden Teil eines hoch motivierten Teams in einer dynamisch wachsenden Unternehmensgruppe. - In unserer zukunftsorientierten Branche...

  • Research Assistant

    vor 3 Monaten

    Wien, Österreich Research Institute of Molecular Pathology Vollzeit

    The Research Institute of Molecular Pathology (IMP) in Vienna pursues world-class research in basic molecular biology. It is located at the Vienna BioCenter and largely sponsored by Boehringer Ingelheim. With over 250 scientists from 40 countries, the IMP is committed to scientific discovery of fundamental molecular and cellular mechanisms underlying complex...

  • Sr. Specialist Quality Assurance

    vor 7 Monaten

    Wien, Österreich MSD Vollzeit

    Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht...

  • Qualified Person

    vor 1 Woche

    Wien, Österreich Talentor Sweden AB Vollzeit

    Unser Auftraggeber, ein österreichisches Unternehmen und Netzwerk an Plasmaspende-Zentren in Europa, gehört zu einer international tätigen und führenden biopharmazeutischen Unternehmensgruppe, die lebensrettende Medikamente aus Plasma herstellt und zu den maßgeblichen plasmafraktionierenden Akteur*innen zählt. **Der Expansionskurs schreitet voran**:...

  • Intern - Research On Trafficking in Persons

    vor 1 Woche

    Wien, Österreich United Nations Vollzeit

    The internship is located in the Crime Research Section, Research and Analysis Branch (RAB), Division for Public Affairs (DPA), United Nations Office on Drugs and Crime (UNODC), Vienna (Austria). The intern will work under the direct supervision of Professional staff of the section. The Research and Analysis Branch (RAB) is centrally responsible within...

  • Responsible Person Austria, Senior Manager Gdp Operational Quality

    vor 4 Wochen

    Wien, Österreich Vertex Pharmaceuticals Vollzeit

    Job Description General Summary: The GDP Operational Quality Senior Manager will act as Responsible Person (RP, "Fachkundige Person") for Vertex Pharmaceuticals Austria, keeping oversight of the local distribution network, ensuring ongoing maintenance of the WDA, leading regulatory inspections, and supporting International Quality in wider regional or...

  • Teamlead Product Industrialization Manager

    vor 8 Stunden

    Wien, Österreich Alstom Vollzeit

    **Req ID**: 244061 We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of...

  • Teamlead Product Industrialization Manager

    Vor 2 Tagen

    Wien, Österreich ALSTOM Vollzeit

    Req ID:244061 We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of more...

  • Account Manager Dach

    vor 5 Monaten

    Wien, Österreich GoStudent Vollzeit

    **Stellenbezeichnung**: Du willst mit uns gemeinsam die Zukunft der Bildung verändern und nachhaltig etwas bewirken? Möchtest du eine Karriere in einem innovativen und herausfordernden Edtech-Unternehmen machen? Komm zu uns und genieße die Zusammenarbeit mit einem internationalen Team von talentierten Denkern, Machern und Visionären. Wir erfinden das...

  • Teamlead Quality in Operations/ Packaging An

    vor 7 Monaten

    Wien, Österreich MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our...

  • Internal Medicine Specialist

    Vor 4 Tagen

    Wien, Österreich Emprego AT Vollzeit

    We have an open position in the beautiful, historical and cultural capital city of Austria, in Vienna. - A specialist doctor for Internal Medicine in Oncology - Qualified in Haematology and internal oncology - Strongly patient orientated and social - Able to work independently and are responsible - Interested in scientific work - On at least level B2 in...

  • Senior Account Executive

    vor 1 Woche

    Wien, Österreich SAP Vollzeit

    **We help the world run better** **Senior Account Executive (f/m/d) Public Sector in Austria** SAP ist einer der weltweit führenden Anbieter von Software für die Steuerung von Geschäftsprozessen und ist langjähriger Partner der öffentlichen Verwaltung in Österreich. Gemeinsam mit unseren Kunden und Partner haben wir uns das Ziel gesetzt, den Standort...