Computerized Systems Quality Assurance Lead

vor 2 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About** the role**

Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takeda´s commitments for patient Safety, Product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data.This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare Laws and regulations, and Takeda policies and procedures. The CS QA Lead also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.

**How you will contribute**:

- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
- Promote and champion support of compliance, quality and best practice-oriented culture regarding Computerized Systems.
- Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests
- Support the development of global CS QA related procedures
- Participate in ongoing operational management activities for global systems including but not limited to demand management, Change Advisory Board and Quality Metrics
- Support qualification activities for global computerized system vendors and 3rd party software providers including Cloud providers and SaaS solutions.
- Provide expertise and support during audits and inspections of Takeda
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Proactively identify risks and issues and drive implementation of pragmatic, compliant, risk-based solutions
- Lead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned
- Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data
- Support the response and remediation of corrective actions and internal audits.
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.

**What you bring to Takeda**:

- Bachelor’s degree in science, Business, Engineering, IT or related discipline or 5 years of equivalent professional experience.
- Minimum 5 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulations as well as working with regulated IT systems and IT teams (mostly virtually)
- Experience in making quality assurance and compliance decisions with regard to software development, validation and support.
- Experience with all phases of software validation and infrastructure qualification.
- Experience with all phases of System Development Lifecycle principles, Processes and procedures.
- Demonstrated multitasking project management and execution skills
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
- Ability to read, analyze and interpret business plans technical procedures, and government regulations
- Proven analytical and problem resolution skills; ability to identify root cause of problems
- Excellent verbal and written communication skills at the functional and technical level as well as fluency in English; German is a plus
- Ability to understand complex business processes and recommend simplification where possible
- Proficient in Microsoft Office products
- Willingness to travel to various meetings on Takeda sites, including overnight trips (some international travel may be required)

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 4.751,92 gross per month (full-time, collective wage agreement for the chemical industry) - **the actual salary depends on your professional experience and qualifications.**
- Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
- Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Fitness Center

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we

  • Quality Assurance Officer

    vor 1 Woche

    Wien, Österreich Symbiotic Research Vollzeit

    **We are looking for an employee to reinforce our team: Quality Assurance**: **Responsibilities**: - Creation, maintenance and continuous improvement of a GxP-compliant Quality Assurance system including e.g. document management, deviations, change control, CAPA, risk analysis, qualifications, validations - Approval of Validation documents (equipment and...

  • Quality Manager

    vor 2 Wochen

    Wien, Österreich Valneva Vollzeit

    **Responsibilities** - Establish, maintain and continually improve the quality assurance management system for all aspects of the activities of Valneva Austria, compliant with coordinated policies for Quality Assurance which are consistent with current GxPs, relevant Health and Safety Regulations and other relevant current legislation - Lead/support projects...

  • Quality Assurance Officer

    vor 1 Woche

    Wien, Österreich Tentamus Vollzeit

    **Responsibilities**: - Creation, maintenance and continuous improvement of a GxP-compliant Quality Assurance system including e.g. document management, deviations, change control, CAPA, risk analysis, qualifications, validations - Securing the validity of analytical performance through appropriate QA measures - Monitoring the GxP conformity of all...

  • Information Systems Assistant

    vor 2 Wochen

    Wien, Österreich United Nations Vollzeit

    This position is located in the Global Technical Team (GTT) of the Department for General Assembly and Conference Management (DGACM), Vienna. The incumbent reports to the QA/DevOps Team Lead. **Responsibilities**: Within delegated authority, the Quality Assurance Engineer will be responsible for the following duties: - Acts as focal point for development...

  • Quality Control

    vor 2 Wochen

    Wien, Österreich Symbiotic Research Vollzeit

    **Location: Wien / Austria**: We are GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA. **Responsibilities **:- Generation of Qualification Plans, Protocols and Reports - Support of different Equipment and Systems owners by providing technical knowledge. - Planning and execution of the qualification of equipment and systems together with the...

  • Quality Control

    vor 2 Wochen

    Wien, Österreich Tentamus Vollzeit

    **Location: Wien / Austria** We are GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA. **Responsibilities** - Generation of Qualification Plans, Protocols and Reports - Support of different Equipment and Systems owners by providing technical knowledge. - Planning and execution of the qualification of equipment and systems together with the...

  • Quality Assurance Lead Und Auditor

    Vor 5 Tagen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: The main responsibility is maintaining and supporting the quality oversight of the GLP QA program of Takeda´s GLP Test Facility in Vienna and the Quality Control testing activities associated with Adventitious Agent Testing (AAT) under GMP. This role includes leading internal and external (supplier) quality audits to assess quality...

  • Quality Assurance Inspector

    vor 2 Wochen

    Wien, Österreich Projects24.co Vollzeit

    **You are a professional certified Quality Assurance Inspector?** Looking for local and global projects to work for ? Then this is your chance to publish your skills. **Responsibilites** Quality assurance inspectors work in factories or manufacturing plants to inspect product quality before they ship products to warehouses or retail locations. They do...

  • Quality Assurance Engineer

    vor 2 Wochen

    Wien, Wien, Österreich Schrack Technik GmbH Vollzeit

    SUPER JOB ZENTRALEWe're looking forQuality Assurance Engineer (m/f/x)Location: WienWorking hours: Full-timeAs the IT of the REWE Group Austria, we work together with our more than 500 employees to develop innovative IT products and services for all our corporate divisions in Austria and abroad, setting the tone for modern trade.In the role of Quality...

  • Quality Assurance Manager

    vor 2 Wochen

    Wien, Wien, Österreich g2 Recruitment Vollzeit

    Freelance Quality Assurance Manager (Hybrid) - 9 MonthsRate: DOELength: 12 Months (open to extension)Contract Type: Freelanceg2 is currently working with a leading energy company near Vienna, expanding an existing gas power plant. The project is scheduled to start in April 2025. This project gives you the chance to be at the forefront of Austria's expanding...

  • Quality Assurance Mitarbeiter

    vor 2 Wochen

    Wien, Wien, Österreich Efinio AG Vollzeit

    Quality Assurance Mitarbeiter (m/w/d)Arbeitsort: Wien, Wiener NeustadtEfinio IT & ENGINEERING ist ein Ingenieurdienstleister, der Leidenschaft in die Realität umsetzt. Unsere erfahrenen Expert:innen beweisen täglich ihre Ingenieurkompetenz – von einzelnen Komponenten und Modulen bis hin zu kompletten Projekten gestalten sie maßgeschneiderte Lösungen...

  • Senior Specialist Quality Assurance Systems

    Vor 5 Tagen

    Wien, Österreich MSD Vollzeit

    **Job Description**: 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...

  • Quality Assurance Research Program Lead Vienna

    vor 1 Woche

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: The **Quality Assurance Research Program Lead **is in charge of maintaining and supporting the quality oversight of the GLP & GCLP QA program of Takeda´s GLP Test Facility in Vienna and the QA oversight of GLP regulated activities in R&D. Additionally he will support non-GxP R&D areas and provide Quality oversight for submission relevant...

  • Head of Digital Quality Assurance

    vor 2 Wochen

    Wien, Österreich ReQuest GmbH Vollzeit

    You see yourself as a pioneer, follow a pragmatic approach and want to expand into new fields? You have profund experience in software developement of regulated products and in depth knowledge of sofware testing? And all this with the advantages of working for the leverage of a global market leader?! We are looking forward to hear from you! Deine Aufgaben...

  • Supervisor Quality Assurance Plasmafraktionierung

    Vor 6 Tagen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **Über die Rolle**: Im Bereich Quality Assurance, in der Plasmafraktionierung suchen wir eine*n Supervisor*in für das Team der Quality on the Shopfloor. In dieser Rolle führen Sie ein Team von bis zu 8 Mitarbeitern und organisieren selbstständig alle Tätigkeiten der Quality Assurance vor Ort in der Produktionsumgebung und berichten in Tier sowie...

  • Qualitätsmanager:in Senior Quality Assurance

    vor 1 Woche

    Wien, Österreich Powerserv Austria GmbH Vollzeit

    **Qualitätsmanager:in Senior Quality Assurance Operations Specialist - Pharma**: Einsatzort Wien Arbeitszeit 38 Std/Woche Entgelt ab 4500 €/Monat Ein renommierter Arbeitgeber und ein abwechslungsreiches Aufgabengebiet ist Ihnen wichtig? Unser Kunde ist ein traditionelles und angesehenes Unternehmen, welches in seine Mitarbeiter (m/w/d) investiert und...

  • Specialist Quality Assurance

    vor 2 Wochen

    Wien, Wien, Österreich MSD Vollzeit

    Unsere Qualitätssicherung gewährleistet, dass alle in unseren Produkten enthaltenen Materialien und Stoffe unter Einhaltung unserer strengen Qualitätsstandards und aller behördlichen Auflagen hergestellt, verarbeitet, geprüft, verpackt, gelagert und geliefert werden. Durch die enge Zusammenarbeit unserer unternehmensinternen Produktionsstätten und...

  • Studentischer Mitarbeiter Quality Assurance

    Vor 7 Tagen

    Wien, Österreich Völker Personal Vollzeit

    Für die Herstellung und für den Vertrieb von Tierpharmazeutika sowie für den Großhandel mit chemischen Erzeugnissen beschäftigt sich unser Kunde in 1210 Wien. Eingestellt wird ab sofort für 25-30 Wochenstunden ein Werkstudent zur administrativen Unterstützung (m/w/d). Führerschein B und eigenes KFZ sind zur Anreise an den Arbeitsort von Vorteil,...

  • Research Quality Assurance Lead Und Auditor

    Vor 6 Tagen

    Wien, Österreich Takeda Pharmaceutical Vollzeit

    **About the role**: The main responsibility is maintaining and supporting the quality oversight of the GLP QA program of Takeda´s GLP Test Facility in Vienna. This role includes leading internal and external (supplier) quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality...

  • Quality Assurance Engineer

    Vor 2 Tagen

    Wien, Wien, Österreich Sixsentix AG Vollzeit

    Company OverviewSixsentix AG is a fully agile organization dedicated to providing exceptional test automation services to our clients. Our team is committed to excellence, constantly pushing the boundaries of innovation and quality.Job DescriptionWe are seeking an experienced Quality Assurance Engineer to join our dynamic team. As a key member, you will be...