QA Expert

2 weken geleden

Amsterdam, Nederland Wacker Chemie AG Voltijd

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.

Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. lts four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA). At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMPcompliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.

To strengthen our team in **Amsterdam,**
we are looking for you as a(n) **QA Expert**

The Quality Assurance Expert is responsible for the review and approval of the lot package, including all batch related documentation and deviations. Based on this review and assessment he/she advises the Qualified Person on the final disposition of the batch. Furthermore he/she is responsible for the review and approval of quality records and provides input for the Quality Management Systems in place. The Quality Assurance Expert participates in project teams in representation of the Quality Assurance department, bringing quality oversight to the teams and the enforcement of the compliance with the current legislation and GMP guidelines.

**Job responsibilities**:

- Review and approval of GMP documents and master batch records;
- Review and approval of batch manufacturing and QC testing records;
- Batch release preparation;
- Handling and assessment of deviations and change controls;
- Participation in project teams as QA project lead and contact person for clients;
- Execution of internal audits according to audit plan and support during external audits (clients and governmental bodies);
- Coordination and maintenance of quality management systems;
- Training of employees with regards to GMP matters.

**Qualifications required**:

- Bachelor degree in the orientation of Analytical Chemistry, (Micro)Biology, Biochemistry or Pharmaceutical Sciences;
- A minimum of 5 years experience in the pharmaceutical industry, preferably in QA;
- Excellent verbal and written communication skills;
- Ability to work with tight deadlines and handle multiple tasks;
- Computer fluency in MS Office, e.g. Word, Excel, PowerPoint. Knowledge of Veeva and SAP is a plus;
- Experience with FDA compliance is a plus;
- Profound knowledge of Dutch and English language, verbal and written;
- You reside in and are eligible to work in The Netherlands (valid work permit).

**What do we offer?**
- **Employment**: A challenging and international position in a professional and informal working environment
- **Compensation**:Attractive salary, holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan
- **Work-life balance**: Flexible working hours (where possible), 30 days of vacation
- **Versatile development opportunities**: Support for professional development, access to online learning platform GoodHabitz

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.

**Reference Code**:28329

  • QA Officer

    2 maanden geleden

    Amsterdam, Nederland Science at Work Staffing Voltijd

    Voor een internationaal biotechnologisch bedrijf te Amsterdam zoeken wij een nieuwe Quality Assurance Officer (QA). In deze functie word je verantwoordelijk voor onder andere:Toezicht op compliance van Good Manufactoring Practice (GMP) binnen productie enlaboratoriaReview van batch documentatie en controle voor QP releaseOpstellen van benodigde QA...

  • QA Officer

    2 maanden geleden

    Amsterdam, Nederland Science At Work Voltijd

    Voor een internationaal biotechnologisch bedrijf te Amsterdam zoeken wij een nieuwe Quality Assurance Officer (QA). In deze functie word je verantwoordelijk voor onder andere: Toezicht op compliance van Good Manufactoring Practice (GMP) binnen productie en laboratoria Review van batch documentatie en controle voor QP release Opstellen van benodigde QA...

  • QA Officer

    2 maanden geleden

    Amsterdam, Nederland Science At Work Voltijd

    Voor een internationaal biotechnologisch bedrijf te Amsterdam zoeken wij een nieuwe Quality Assurance Officer (QA). In deze functie word je verantwoordelijk voor onder andere: Toezicht op compliance van Good Manufactoring Practice (GMP) binnen productie en laboratoria Review van batch documentatie en controle voor QP release Opstellen van benodigde QA...

  • Medior QA Consultant

    3 maanden geleden

    Amsterdam, Nederland BearingPoint Voltijd

    Durf de grenzen van kwaliteitsmanagement te verleggen!Welkom bij BearingPoint, waar we geloven dat samen meer is dan een bedrijf; het is een ervaring, een reis die strategie, technologie en ondernemerschap samenbrengt in een atmosfeer van innovatie. Als Medior QA Consultant nodigen we jou uit om deel uit te maken van ons gepassioneerde team en een cruciale...

  • QA Manager Biotech

    3 maanden geleden

    Amsterdam, Nederland Science at Work NL Voltijd

    Job descriptionAs a Quality Assurance Manager you have the end responsbility for the quality assurance department of a medium sized biotech firm, specializing in development and production of novel therapeutics. You will lead a team of +/- 10 QA officers and support personnel, ensuring company compliance to the different quality rules and guidelines, among...

  • QA Director

    2 maanden geleden

    Amsterdam, Nederland Independent Recruiters Werk op afstand Freelance Voltijd

    Are you a results-driven leader passionate about quality?Join the largest dairy company in the Netherlands as QA Director and drive excellence across the global supply chain. Shape and execute cutting-edge quality strategies, ensure the highest safety and taste standards, and lead a culture of continuous improvement.Ready to make a lasting impact in a...

  • QA Director

    2 maanden geleden

    Amsterdam, Nederland Independent Recruiters Werk op afstand Freelance Voltijd

    Are you a results-driven leader passionate about quality?Join the largest dairy company in the Netherlands as QA Director and drive excellence across the global supply chain. Shape and execute cutting-edge quality strategies, ensure the highest safety and taste standards, and lead a culture of continuous improvement.Ready to make a lasting impact in a...

  • Software Quality Expert

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Brand New Day Voltijd

    We are seeking a highly motivated and experienced Senior QA Engineer to lead our quality assurance efforts in driving excellence in software quality across teams and departments.The ideal candidate will have a strong background in test automation, process optimization, and team leadership. This is an excellent opportunity for someone looking to make a...

  • Senior QA Logistics Specialist

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Kyowa Kirin Voltijd

    About Kyowa Kirin">Kyowa Kirin is a leading pharmaceutical company dedicated to improving human health through innovative research and development.As a Senior QA Logistics Specialist, you will play a critical role in ensuring the quality and compliance of our medicinal product distribution activities across the EMEA region.Salary: The estimated annual salary...

  • Senior QA Engineer

    7 maanden geleden

    Amsterdam, Nederland Knab Voltijd

    Senior QA Engineer (Test Strategy/Automation) Knab was founded in 2 because we wanted to do things differently. Simpler, smarter and more advantageous for our customers. Because we believe we can help everyone maximize their financial affairs. "Feel at ease when it comes to your finances. Every day. By combining smart technical solutions with a healthy...

  • Senior Data Discovery and Enrichment Expert

    3 maanden geleden

    Amsterdam, Nederland Elsevier BV Company Voltijd

    About the Role   As a Senior Data Discovery and Enrichment Expert within a team that manages and delivers support to many products, the person will contribute to the maintenance and continuous improvement of the quality standards for various engineering products (e.g., Knovel) and databases of peer-reviewed, full-text scientific, technical and health...

  • Team Lead Quality Assurance

    7 maanden geleden

    Amsterdam, Nederland Artsen Zonder Grenzen Voltijd

    **Job Brief**: You are responsible for the performance of the organisation’s quality assurance, expert advice and support regarding quality assurance and the procurement of pharmaceuticals or medical devices or specialised food products by leading, **MSF is an international, independent medical humanitarian organization. We are a non-profit, self-governed...

  • Product Assurance Expert

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Fairphone Voltijd

    Company Overview: Fairphone is a social enterprise driving change in the electronics industry by establishing a market for ethical products, motivating the entire industry to act more responsibly. We pride ourselves on being socially inclusive and having a diverse group of people with different backgrounds.Job Description: We are looking for a Product...

  • Emailing & Deliverability Expert (f/m/d)

    7 maanden geleden

    Amsterdam, Nederland Decathlon Technology Voltijd

    CUSTOMER GROWTH IS HIRING!  DECATHLON is accelerating its digital transformation with the ambition of becoming THE digital platform for sportsmen and women that will enable users to access the entire world of sport at the click of a button (Equipment, Activities, Coaching, etc.). The MARTECH team brings together tools and solutions for digital...

  • Qrc Continu Verbetermanager

    1 maand geleden

    Amsterdam, Nederland Sanquin Voltijd

    **Locatie** - Amsterdam **Werkweek** - 32-36 uur **Opleiding** - HBO **Sluitingsdatum** - 12 december 2024 **Functiegebied** - QA **Vacature nr.** - 1271 De QRC afdeling van Sanquin zoekt een QRC Continu Verbetermanager voor 36 uur per week, die ervoor zorgt dat patiënten altijd en overal kunnen rekenen op veilige bloedproducten. **Waar kom je te...

  • Lead Validation and Compliance Expert

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Allucent Voltijd

    We are seeking a Senior Validation and Compliance Lead (India) to join our team.About the RoleThis position is responsible for leading the validation and compliance activities within Technology & Innovation assigned projects at Allucent. The role involves controlling and monitoring the validation and compliance status of GxP impacting systems, ensuring...

  • Electrical Project Manager for Pharmaceutical Investment Projects

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland RnB Consultancy Voltijd

    Take your career to the next level as an Electrical Project Engineer with RnB Consultancy, where you'll be responsible for overseeing electrical technical projects in pharmaceutical investment projects.Your key responsibilities will include:Planning, preparation, execution, and reporting of electrical technical projects, ranging from small modifications to...

  • Quality Assurance Director Lead

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Independent Recruiters Voltijd

    About the Role:We are seeking a highly skilled Quality Assurance Director Lead to join our team at Independent Recruiters. As the Global QC Director, you will be responsible for defining and implementing the Quality Control strategy across the organization.Main Responsibilities:Lead QC Strategy: Develop and execute a long-term QC roadmap to improve quality...

  • Senior consultant

    7 maanden geleden

    Amsterdam, Nederland ITL Netherlands Voltijd

    Job Description In the role of a DR/Resilience/QA expert, you will work on Dress Rehearsal drills, Quality Assurance, and simulations project. It is required to have experience on DR drills, simulations, implemented DR solutions and technologies, anchored the recovering of systems and data from outages and failures, tested both during DR and recovery...

  • Customer Support Medewerker Laboratorium

    3 maanden geleden

    Amsterdam, Nederland Science at Work Staffing Voltijd

    Dit betreft een vacature bij een vooraanstaand chemisch laboratorium die een breed scala aan analyses uitvoert voor bedrijven. Naast dat ze een uitgebreid laboratorium hebben met veel verschillende analyseapparatuur, kent dit bedrijf een supportafdeling die samen zorg draagt voor de communicatie met de bedrijven die de analyses hebben aangevraagd. Je zal...