Pv Quality Management Specialist

vor 6 Monaten

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our European headquarters in Munich we are looking for a

**PV Quality Management Specialist (M/F/x)**:
**The position**:
The PV Quality Management Specialist will work with and support the PV Quality Management team to maintain and enhance the Daiichi Sankyo PV Quality Management System.This position is responsible for the quality control of PV tasks fulfilled by DSE (EU headquarter office), EU affiliates, CROs and license partners and proactively monitors quality of all PV tasks (including compliance monitoring) and ensures operational standards are well-maintained.
This position will also support other activities in the PV quality management area as needed for the overall optimal function of the team and is expected to contribute to the global projects together with the PV Quality Management Lead and other team members as part of the global Quality, Compliance and PSMF team to enhance the Daiichi Sankyo Global PV Quality Management System.

**Roles & responsibilities**:

- Global maintenance of PSMF and related documents as well as global coordination of all PSMF related activities with relevant stakeholders (cross-regional and cross-functional)
- Manage and maintain the global Phamarcaovigilance System Master File
- Organize compilation activties including vendor coordination
- Identify process improvements and harmonizations
- Systematical deviation Management, CAPA plan development and tracking of CAPA status for deviations of any source
- Coordination of planned CAPA activities with relevant CAPA stakeholders
- Collection of implemented items
- Review/QC evidence ensure consistency with the CAPA plan
- Coordination and handling of escalated quality events in collaboration with QA functions in the trackwise system
- Act as system expert for RxLogics in the context of compliance/KPI outputs
- Plan, coordinate and process compliance as well as KPI report
- Provide appropriate data visualization
- Analyse and identify concerns and key messages from the data
- Continuously identify and propose process enhancement of the system

**Professional experience & education**:

- Bachelor degree in a scientific and/or quality related area, Master preferred
- 2-5 years in PV Quality related tasks
- Experience in the field of safety data processing or CAPA management
- Experience with PSMF related work and knowledge of respective regulations
- Good or excellent computer and presentation skills
- Good or Excellent written and verbal communication skills in English
- Highly reliable with accurate operating principles
- Analytic and systematic approach with good problem solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
- Flexible and adaptable

**Why work with us?**:

  • Quality Management Specialist

    vor 5 Monaten

    Munich, Deutschland Hays Vollzeit

    **Quality Management Specialist** (m/w/d) **Anstellung bei der Hays Professional Solutions GmbH** **München** **Startdatum: sofort** Referenznummer: 743112/1 **Bewerbung starten** **Ihre Aufgaben**: - Erstellung von Konformitäts-/KPI-Ausgaben und des ROD-Moduls zur systematischen Verfolgung und Archivierung/Ablage von CAPAs, um die rechtzeitige...

  • Global Pv Specialist

    vor 6 Monaten

    Munich, Deutschland Acino Pharma Vollzeit

    **Munich, Germany**: Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich. Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on...

  • Quality Assurance Specialist

    vor 4 Wochen

    Munich, Deutschland Amazon TA Vollzeit

    We are seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the highest quality of our software products. This includes identifying and reporting defects, testing software, and collaborating with cross-functional teams to resolve issues.As a Quality Assurance Specialist, you will be working...

  • Quality Assurance Specialist

    vor 4 Wochen

    Munich, Bayern, Deutschland myposter GmbH Vollzeit

    We are seeking a skilled Quality Assurance Specialist to join our team at {company}. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality products by identifying and reporting defects and discrepancies.Key responsibilities include:Conducting thorough testing of software applications to ensure they meet quality...

  • Quality Management Specialist

    vor 5 Monaten

    Munich, Deutschland Precipoint Vollzeit

    **Wir digitalisieren und vernetzen Labore!**: Die PreciPoint GmbH mit Hauptsitz in Garching entwickelt intelligente Mikroskopsysteme und innovative Analysesoftware, und trägt somit zur Digitalisierung und Weiterentwicklung von Laboren bei. Unser Kundenkreis erstreckt sich von medizinischen Laboren und Forschungseinrichtungen bis hin zur Industrie. Zur...

  • Pv Product Management Expert

    vor 6 Monaten

    Munich, Deutschland Allen Recruitment Consulting Vollzeit

    **Location**: Munich, Bayern, Germany**Type**: Permanent - **Job** #24854 Are you passionate about spearheading advancements in solar technology and playing a pivotal role in the global tech industry? Do you possess a deep understanding of market trends and a solid background in energy stage? If so, we invite you to consider joining our client as a PV...

  • Life Science Compliance Specialist

    Vor 3 Tagen

    Munich, Bayern, Deutschland ARCONDIS Vollzeit

    Job OverviewWe are seeking an experienced Life Science Compliance Specialist to join our team at ARCONDIS. This is a fantastic opportunity for a qualified professional to take on a key role in ensuring the quality and integrity of our products.Key ResponsibilitiesThe successful candidate will be responsible for:Qualifying and validating laboratory equipment...

  • Supplier Quality Specialist

    vor 6 Monaten

    Munich, Deutschland BOEING Vollzeit

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...

  • Leading Quality Assurance Specialist for Rail Vehicles

    vor 3 Wochen

    Munich, Bayern, Deutschland GULP – experts united Vollzeit

    At GULP – experts united, we are currently seeking a seasoned Quality Assurance Specialist to lead our quality management efforts in the rail vehicle sector. Located in Munich, this role presents an exceptional opportunity for professionals with a passion for ensuring the highest standards of quality in production.Salary and Job SecurityWe offer a highly...

  • Quality Specialist

    vor 5 Monaten

    Munich, Deutschland Sungrow EMEA Vollzeit

    Your mission Hey there and welcome to your new Opportunity with us. Being a Quality Manager is an exciting task, since you are the superhero our clients need. You know what setup of our solutions will satisfy their needs, therefore, these here are your most important tasks: - Establish the quality process between client side, internal technical teams, and...

  • Quality Specialist

    vor 6 Monaten

    Munich, Deutschland Sungrow EMEA Vollzeit

    Your mission Hey there and welcome to your new Opportunity with us. Being a Quality Manager is an exciting task, since you are the superhero our clients need. You know what setup of our solutions will satisfy their needs, therefore, these here are your most important tasks: - Establish the quality process between client side, internal technical teams, and...

  • Quality Management Specialist

    vor 5 Monaten

    Munich, Deutschland Precipoint Vollzeit

    **Wir digitalisieren und vernetzen Labore!**: Die PreciPoint GmbH mit Hauptsitz in Garching entwickelt intelligente Mikroskopsysteme und innovative Analysesoftware, und trägt somit zur Digitalisierung und Weiterentwicklung von Laboren bei. Unser Kundenkreis erstreckt sich von medizinischen Laboren und Forschungseinrichtungen bis hin zur Industrie. Zur...

  • Senior Supplier Quality Assurance Specialist

    vor 2 Wochen

    Munich, Bayern, Deutschland Sono Motors Vollzeit

    We are seeking a Senior Supplier Quality Assurance Specialist to join our team at Sono Motors.As a key member of our Supply Chain department, you will play a crucial role in ensuring the quality and reliability of materials and components sourced from our suppliers. Your primary responsibility will be to develop, implement, and maintain supplier quality...

  • Tiktok Commerce

    vor 7 Monaten

    Munich, Deutschland TikTok Vollzeit

    Responsibilities About Us TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, London, Paris, Berlin, Dubai, Singapore, Jakarta, Seoul and Tokyo. Why Join Us Creation is the core of TikTok's purpose. Our platform is built to help...

  • Senior Quality Assurance Specialist

    vor 2 Wochen

    Munich, Bayern, Deutschland TÜV SÜD Vollzeit

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at TÜV SÜD America. The successful candidate will lead third-party quality audits and assessments in accordance with our Corporate Policies.This role is responsible for managing the SQF Program, training new auditors, business development, performing audits, technical...

  • Data Quality Specialist bei Marktguru

    vor 2 Wochen

    Munich, Bayern, Deutschland marktguru Deutschland GmbH Vollzeit

    Bei der marktguru Deutschland GmbH ist als Data Quality Specialist unser Content-Management Team in der digitalen Vermarktung und Betreuung von Kampagnen sowie der Optimierung des Contents im CMS-System unterstützt. Wir suchen nach einer qualifizierten Person, die unsere Datenbanken durchgängig auf Aktualität und Vollständigkeit prüft.Besondere Aufgaben...

  • Risk Management Specialist

    vor 4 Wochen

    Munich, Bayern, Deutschland Bosch Sicherheitssysteme GmbH Vollzeit

    Bosch Sicherheitssysteme GmbH is seeking an experienced Risk Management Specialist to join their team. As a Specialist for Internal Controls Systems, you will play a critical role in establishing and continuously improving an Enterprise Internal Control System (ICS) to ensure the achievement of corporate objectives.Key Responsibilities:Establish and maintain...

  • Data Management Specialist

    Vor 3 Tagen

    Munich, Bayern, Deutschland Munich Re Vollzeit

    Job SummaryWe are seeking an experienced Data Management Specialist to join our team at Munich Re. In this role, you will be responsible for systematic collection and preparation of relevant structured and unstructured data as a basis for actuarial calculations.Key ResponsibilitiesConsolidate various external and internal data sources into quality assured...

  • Product Management Pv/ Energy Storage

    vor 5 Monaten

    Munich, Deutschland Allen Recruitment Consulting Vollzeit

    **Location**: Munich, Bayern, Germany**Type**: Permanent - **Job** #24854 Are you enthusiastic about leading the evolution of solar technology and being a key player in the global tech industry? Do you possess a keen understanding of market trends and a strong background in energy stage? If so, consider joining our team as a **Product Management Lead f...

  • Senior Specialist Quality Management

    vor 5 Monaten

    Munich, Deutschland Infineon Technologies Vollzeit

    I n your new role you will: D - evelop, coordinate and approve qualification plans and guide the implementation in the reliability lab P - erform project and product-specific risk assessments (e.g. quality, cost, time) to support product definition and development P - ro-actively work on problem solving strategies together with the customer, developers,...