- Implement, communicate and maintain Company's quality systems and policies at the facility, in compliance with Marken's Global quality management system requirements and local requirements.
- Effectively interact with other Marken department and stake holders to maintain quality and help introduce new quality improvements.
- Agree standards and define quality processes and procedures through effective controlled document issue and management.
- Interact with clients on Quality Assurance (QA)/ GxP related matters.
- Write quality assurance procedures as required for GxP Compliance.
- Participate and monitor the internal audit schedule and perform/ or delegate, including report preparation, assessment and tracking of associated corrective and preventive actions (CAPA). To ensure that a self-inspection audit is done once a year in the local Marken facilities.
- To maintain the vendor qualification program, this includes, but it is not limited to the QTA (Quality Technical Agreements) updates and performing Quality audits.
- Host client audits and regulatory inspections, manage the audit report responses and act as Marken's main representative, including and preparing of appropriate materials required within those audits when applicable.
- Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.
- Identify relevant GxP/ Quality related training needs and deliver or make they are deliver where required.
- Maintain the oversight of review and release of incoming material receipts in accordance with product specification where applicable.
- Perform QA role in qualification/validation activities.
- Manage/Approve the change control.
- Co-ordinate any product recall as required and ensure that a mock recall is carried out on an annual basis where applicable.
- Prepare and acquire appropriate data to complete trending and KPI reporting requirements.
- Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.
- Comprehensive knowledge of Good Manufacturing Practice guidelines
- At least 5 years held position as in Quality Assurance role within a GMP regulated position.
- Good interpersonal skills
- Organized, a methodical and efficient approach to work.
- Proficient use of Microsoft Office.
- Fluent in English and Dutch both written and oral.
- Senior or Lead Auditor experience in self inspections, internal and external audit.
-
Quality Manager
2 dagen geleden
Michael Page NederlandKwaliteitsbeheer van voedsel en proces van productie · Kwaliteitsverantwoordelijke - Vlaams-Brabant - Sector : agrovoedingsindustrie · Over onze klantOnze klant is een toonaangevend Belgisch bedrijf in de agrovoedingssector.FunctieomschrijvingWaarborgen van de kwaliteit · ...
-
Manager Quality
2 weken geleden
GrijsGroen Amstelveen, NederlandAls Manager Vastgoedprogrammering ben je verantwoordelijk voor het leiden van een team van vastgoedprogrammeurs en verkoopvoorbereiders. Leiding geven aan een team van 14 vastgoedprogrammeurs en verkoopvoorbereiders. · Uitgebreid pakket secundaire arbeidsvoorwaarden, waaronder o ...
-
Quality Assurance Program Manager
1 week geleden
Forbo Assendelft, Nederland**De divisie Flooring Systems biedt een breed en aantrekkelijk assortiment milieuvriendelijk linoleum, hoogwaardige vinylvloeren, schoonloopsystemen, tapijttegels, naaldvilt, en Flotex, de wasbare textielen vloerbedekking. Dankzij hun voortreffelijke technische eigenschappen en a ...
-
Manager Audit Quality
5 dagen geleden
KPMG-Netherlands Amstelveen, NederlandManager Audit Quality - Root Cause Analysis · Het uitvoeren van oorzakenanalyses is een belangrijk onderdeel van ons systeem van kwaliteitsbeheersing en draagt bij aan de continue verbetering van de de kwaliteit van uitgevoerde controles. De Audit Quality Professional Practice (A ...
-
Manager Audit Quality
1 week geleden
KPMG-Netherlands Amstelveen, Nederland(Senior) Manager Audit Quality - Monitoring & Measurement · Het Monitoring & Measurement-team is een nieuw opgericht team. Ons doel is het bewaken en verbeteren van de informatiekwaliteit binnen KPMG. Het ondersteunt initiatieven zoals Audit Quality Indicators, Data-driven toezic ...
-
Manager Audit Quality
1 week geleden
KPMG Amstelveen, NederlandWat ga jij doen als Manager Audit Quality - Root Cause Analysis? · Je maakt deel uit van het team dat verantwoordelijk is voor het uitvoeren van oorzakenanalyses op thematische en engagement specifieke vraagstukken. Je bent verantwoordelijk voor het uitvoeren van de analyses same ...
-
Quality Manager Systems
3 dagen geleden
FrieslandCampina Amersfoort, NederlandWe are seeking a dynamic Quality Manager who rigorously upholds the integrity of quality within our business by implementing a unified quality management system and by fostering collaborative teams, creating alliances, and cultivating partnerships with internal colleagues and sup ...
-
Internationale Supplier Quality Manager binnen de luchtvaart
5 dagen geleden
CareerValue Hoofddorp, NederlandDe Organisatie:Voor een goede klant van ons in de omgeving van Schiphol ben ik op zoek naar een Supplier Product Quality Manager/Engineer. Het betreft een gloednieuwe positie, waarbij het cruciaal is dat je over voldoende ervaring beschikt om zelfstandig een quality control/ qual ...
-
Quality Assurance Manager
1 week geleden
Ferring Pharmaceuticals Hoofddorp, Nederland VoltijdJob Description: · At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology, and uro ...
-
Process & Quality Manager
1 week geleden
Croonwolter&dros B.V. Beverwijk, NederlandDe functie · De functie · In de functie van process & quality manager ben je verantwoordelijk voor het bewaken en beheren van het vastgestelde Kwaliteitsbeleid in VOF's en in projecten (Quality Assurance). Je adviseert diverse projectteams over kwaliteitszaken en stelt auditpla ...
-
Watchmaker - Netherlands (M/F/x)
3 dagen geleden
Breitling Lijnden, Nederland**Breitling **stands apart from other watch brands with its focus on casual, sustainable and inclusive luxury. We are looking to for a** Watchmaker** to join our **#Squad **at** Lijnden, The Netherlands. **At this position, reporting to Workshop Manager, you will be responsible f ...
-
Warehouse Associate
4 dagen geleden
Marken Lijnden, Nederland**Title**: · Warehouse Associate · **Job Purpose**: · The Warehouse Associate is responsible for stock management and overall warehousing for the Marken Branch. Will work in conjunction with all Marken operated branches and their agents. · **Main Duties and Responsibilities**: · ...
-
Internationale Supplier Quality Manager binnen de luchtvaart
19 uur geleden
CareerValue Hoofddorp, NederlandDe Organisatie: · Voor een goede klant van ons in de omgeving van Schiphol ben ik op zoek naar een Supplier Product Quality Manager/Engineer. Het betreft een gloednieuwe positie, waarbij het cruciaal is dat je over voldoende ervaring beschikt om zelfstandig een quality control/ q ...
-
Category Quality Manager
2 weken geleden
Rituals Amsterdam, NederlandPURPOSE OF THE JOB · The quality department is responsible for ensuring the performance of the Rituals assortment, product specifications, and that all products surpass predefined quality standards prior to market introduction. In addition, the team ensures that all products are ...
-
Category Quality Manager
2 dagen geleden
Knewin Amsterdam, NederlandJob Description · Rituals is rapidly growing. We are steadily expanding in new territories, opening new stores and growing our online presence. Think globally (EU, Asia, Middle East), think opening over 200 new stores per year. With this growth, our quality ambitions are growing ...
-
Category Quality Manager
1 week geleden
Cosmetics Business Ltd. Amsterdam, NederlandAre you an impressive quality assurance or technology specialist with a love of all things beauty? · Do you juggle projects with ease, overcoming problems and hitting deadlines? · Join a brand that creates luxury products for body and home that benefit people and the planet, with ...
-
Category Quality Manager
2 weken geleden
Rituals Cosmetics Enterprise B.V. Amsterdam, NederlandPURPOSE OF THE JOB · The quality department is responsible for ensuring the performance of the Rituals assortment, product specifications, and that all products surpass predefined quality standards prior to market introduction. In addition, the team ensures that all products are ...
-
Internationale Supplier Quality Manager binnen de luchtvaart
2 dagen geleden
CareerValue Hoofddorp, NederlandDe Organisatie:Voor een goede klant van ons in de omgeving van Schiphol ben ik op zoek naar een Supplier Product Quality Manager/Engineer. Het betreft een gloednieuwe positie, waarbij het cruciaal is dat je over voldoende ervaring beschikt om zelfstandig een quality control/ qual ...
-
Data Quality Manager
5 dagen geleden
FTE Groep B.V. Utrecht, Nederland CDIWat doe je? · Met jouw passie voor data ga je een belangrijke rol spelen in het beheer en de optimalisatie van data. Als Data Quality Manager beheer je data en zorg je ervoor dat jouw team, afdeling of organisatie toegang heeft tot betrouwbare, accurate en relevante informatie. J ...
-
Category Quality Manager
1 week geleden
Rituals Amsterdam, NederlandPURPOSE OF THE JOB · The quality department is responsible for ensuring the performance of the Rituals assortment, product specifications, and that all products surpass predefined quality standards prior to market introduction. In addition, the team ensures that all products are ...
Quality Manager - Lijnden, Nederland - Marken
1 week geleden
Beschrijving
Description
Title: Quality Manager Job Purpose: The Quality Assurance Manager (QAM) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken's Storage, Distribution and Transportation, Kit Production Facility. The QAM also need to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001. Main Duties and Responsibilities:Requirements:
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
Moving Our World Forward by Delivering What Matters.
#LI-AD1 IND123
