Senior Quality Assurance Pharma

hace 7 meses

Gijon, España Wacker Chemie AG A tiempo completo

**Senior Quality Assurance Pharma (QA)**.

Are you looking for a job in León, in a dynamic, globally active technology company - yet at the same time, you appreciate a value-oriented, trusting company? If so, we offer you an exciting job where you will be part of a global team oriented to multiculturalism and equality.

Recently, ADL BIOPHARMA and WACKER have joined forces, and now, WE ARE ONE. With this union, we are stronger, we have a worldwide presence, with production sites on three continents and almost 16,000 employees in 70 countries.

We are a leading group in the biotechnology sector, and we produce for multiple markets: food, cosmetics, fragrances... Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together.

To strengthen our team in León, we are looking for you as a **Senior Quality Assurance Pharma (QA)**.

In order to strengthen our Quality Assurance department, we are looking for people like you to fill the position Senior Quality Assurance Pharma (QA).

**Your Responsibilities**:

- Ensure that the products of our Pharma business line meet all the necessary requirements before reaching the customer.
- Exercise the pharmaceutical technical direction of the company.
- Collaborate with the necessary departments to ensure that the production process and product life cycle complies with GMPs and/or applicable quality standards.
- Ensure the internal and external audit program, participating in internal and external audits.
- Release product batches.
- Oversee the corrective and preventive action program.
- Review manufacturing batch documentation.
- Investigate deviations together with the teams involved and ensure proper investigation of deviations that occur.
- Maintain and manage the documented information system.
- Elaboration and review of reports and protocols required by the system in the field of quality (validations, qualifications, product quality reviews, technical memory, etc...).
- Detection and analysis of needs, preparation of improvement proposals and risk analysis.
- Track, maintain and develop system indicators to ensure process control status and product quality.
- Ensure proper planning and evaluation of necessary change controls in the quality system.
- Assisting authorities during inspections.
- Complaint management, following up on complaints.
- Preparation of regulatory documentation to be sent to the corresponding regulatory agencies.
- Ensuring that manufacturing is performed in accordance with the records approved by the authorities.

**Your profile**

**Education**:

- University Degree in Pharmacy
- Specialist knowledge of pharmaceutical GMP standards Knowledge of GMP standards.

**Experience**:

- At least 2 years of professional experience in a similar position in the Pharma sector.

**Skills**:

- Communication skills and ability to communicate with contracting agencies/clients.
- High level of English (written and spoken).
- Ability to work in interdisciplinary and international teams.
- Initiative, independence and great ability to collaborate between departments.
- Knowledge in the elaboration of regulatory documentation.

You can find an overview of benefits at WACKER on our careers page.

As an international company, we welcome the diversity of people. We consciously promote equal opportunities and a diverse, inclusive culture in our teams - this is what makes us successful.

  • Senior Quality Assurance Associate-entorno

    hace 7 meses

    Gijon, España NonStop Consulting A tiempo completo

    ¿Eres un profesional experimentado en el ámbito de la Garantia de Calidad en la Industria Farmacéutica? ¿Deseas trabajar en un entorno innovador y con oportunidades de desarrollo profesional? ¡Tenemos la posición perfecta para ti como Senior Quality Assurance Associate en nuestro cliente! Beneficios: - Entorno de trabajo excepcional: Te ofrecemos un...

  • Quality Assurance Associate Pharma/biotech

    hace 7 meses

    Gijon, España NonStop Consulting A tiempo completo

    Nuestro cliente es una empresa líder en el sector farmacéutico y biotecnológico con planes de internacionalización para el futuro. Esto significa que tendrás oportunidades para desarrollar tu carrera y trabajar a nível internacional a medida que la empresa crece. Hemos llevado a cabo proyectos exitosos en el pasado y nuestros datos indican un...

  • QA Associate

    hace 6 meses

    Gijon, España NonStop Consulting A tiempo completo

    QA Associate -Iberian scope innovation Our client is seeking QA Associate to join a **Spain and Portugal R&D industry innovator in pharma **operating within the pharmaceutical and healthcare area. The QA Associate will be responsible for being the primary technical support person for the manufacturing processes assurance. This is an excellent opportunity...

  • Manufacturing Operator

    hace 7 meses

    Gijon, España PCI Pharma Services A tiempo completo

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. - Comply with manufacturing area safety...

  • Especialista Senior de Garantia de Calidad-leon

    hace 7 meses

    Gijon, España NonStop Consulting A tiempo completo

    Nuestro cliente, una empresa líder en el sector Pharma, está buscando un Especialista Senior de Aseguramiento de Calidad para unirse a su equipo en Leon. Si eres un profesional serio y estás buscando nuevas oportunidades de desarrollo en tu carrera, esta posición puede ser perfecta para ti. Beneficios: - Oportunidades de desarrollo profesional: Nuestro...

  • Senior Csv Expert

    hace 7 meses

    Gijon, España Bacthera A tiempo completo

    Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we...

  • Senior Qualification

    hace 7 meses

    Gijon, España Bacthera A tiempo completo

    Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we...

  • Operario de Produccion

    hace 1 semana

    Gijon, España LSNE-León, S.L.U. A tiempo completo

    Prosperar en un entorno dinámico y desafiante en una organización de desarrollo y fabricación. Buscando sobresalir a través del auto-liderazgo y el compromiso del equipo. Si esto te describe, entonces no busques más allá de PCI Pharma Services. Contamos con la experiência, los conocimientos y una trayectoria de éxito en la finalización del...

  • HR Director

    hace 7 meses

    Gijon, España PCI Pharma Services A tiempo completo

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Summary Under the supervision of the...

  • Senior Vat Analyst

    hace 6 días

    Gijon, España International Flavors & Fragrances A tiempo completo

    Senior VAT Analyst Key Responsibilities - Review of VAT returns and other indirect tax related reports prepared by team members and prepare VAT returns in case needed. - Ensure quality and legal compliance in VAT by random checks of VAT returns and other tax declarations before submission to local tax authorities. - Regular feedback and strong support to...

  • Compliance Monitoring Manager

    hace 7 meses

    Gijon, España Ebury A tiempo completo

    Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. **Compliance Monitoring manager** **Based in either London, Malaga or Leon - 4 days in the office, 1 day...

  • Compliance Monitoring Manager

    hace 7 meses

    Gijon, España Ebury A tiempo completo

    Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top 15 European Fintechs to work for by AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. **Compliance Monitoring manager** **Based in either London, Malaga or Leon - 4 days in the office, 1 day...

  • Future Wave

    hace 7 meses

    Gijon, España Izertis A tiempo completo

    Ubicación- Gijón, (España)- Contrato- Indefinido- Jornada laboral- Tiempo completo- Sector- Internet y tecnología- Vacantes- 1**Descripción de la oferta**: Future Wave - Data Scientist Junior ¿Buscando tu primer reto profesional después de acabar tus estudios? ¿Quieres hacer prácticas y aplicar todo lo aprendido en la carrera? Si es así, tenemos...

  • Senior Csv Expert

    hace 7 meses

    Gijon, España Bacthera Spain, SL A tiempo completo

    As a successful CSV Engineer you ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities. You are responsible for planning, developing and executing Computer System Validations for 4 Facilities. You will report to the global...

  • Service Center Associate Buyer

    hace 1 semana

    Gijon, España International Flavors & Fragrances A tiempo completo

    Responsible for the entire buy process to include preparing, negotiating, managing and coordinating agreements supporting the procurement of various materials and/or services. Serve as the buyer of record with execution authority for agreements categorized in alignment with Differential Management Efficiency and/or Essential Buy Quadrants. Focus is on...

  • UX Design Lead

    hace 1 semana

    Gijon, España DXC Technology A tiempo completo

    **Essential Job Functions** - Performs complex design, implementation, and maintenance of multi product modules/sub-systems to ensure that business needs are met. Assists in outlining new product/service business case justification to ensure that proposed solution is capable of delivering articulated business benefits to clients. - Participates in product...

  • Financial Planning

    hace 7 meses

    Gijon, España Ebury A tiempo completo

    Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. **FP&A Manager** **Ebury - León Office - 4 days per week office based working - 1 day per week working...

  • Commercial Project Manager

    hace 8 meses

    Gijon, España Siemens Energy A tiempo completo

    Experienced Professional **Manage the project throughout the projectLife Cycle** - Ensures correct methodology for evaluation of risk and opportunities as defined, e.g. in FRG, PM guide - Supports the PM in identifying, evaluating, assessing risks & opportunities, strategies and response activities - Ensures adherence of NCM regulations, incl. role of the...