Computer Systems Quality Manager
Il y a 6 mois
We are currently looking for a Computer Systems Quality Manager.
Key Accountabilities/Responsibilities:
- Develop the Computer Systems (CS) Quality strategy
- Manage the CS Quality audit program
- Create, review and manage the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports
- Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
- Lead and support GxP-determination and validation activities for global CS systems
- Evaluate, test, and validate software and CS services
- Support the creation of SOPs as author, reviewer, or expert
- Lead or collaborate on Quality projects to implement, change or upgrade CS systems and processes
- Support local CS QA as the Subject Matter Expert and provide global guidance
- Develop and implement QA problem reporting processes and systems
- Analyse deficiencies in service or performance and recommend product or service improvements to address problems
- Ensure computerised systems comply with all applicable GxP regulatory and the company’s requirements throughout the life cycle for the systems
- Designs and implements defect reduction programs
Desired Skills and Experience:
- Master’s degree in Sciences or Biological Engineering
- Proven experience in computer systems validation and time spent in quality assurance/compliance function
- Expert knowledge in Software Development Life Cycle (SDLC), IT Quality Management Systems, Computer Systems Validation, internal and external audits
- Good knowledge of CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11....)
- Experience with the implementation and maintenance of electronic Quality and Document Management system(s)
- Knowledge of relevant scientific discipline or equivalent through education and experience.
- Knowledge of Gxp regulatory requirements is preferres (i.e. GCP, GLP, GMP)
- Team player and good communication skills.
- Quality-minded individual who is accurate in execution and reporting
- Flexible attitude, capable of picking up the tasks that require attention.
- Proficiency with MS Office & SharePoint.
- Fluent in English - our working language.
**Offer**:
- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company.
LI-Onsite
-
Computer System Quality Manager
Il y a 7 mois
Gent, Belgique MindCapture Temps pleinCOMPUTER SYSTEM QUALITY MANAGER - Biotech- Ghent & remoteWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...
-
Associate Computer System Validation
Il y a 4 mois
Gent, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the...
-
Manager - Application Validation & Quality
Il y a 6 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our BIS team, argenx is looking for a (Senior) Manager - Application Validation and Quality. The (Senior) Manager - Application Validation and Quality is responsible for the day to day operations and coordination of all activities relating to the argenx Computer Systems Validation (CSV) Process. This ranges from Initial Impact...
-
Quality Systems Associate
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinQuality Systems Associate CAR-T (M/V/X) Janssen Pharmaceutica, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Associate CAR-T. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a...
-
Sr. Manager Quality Systems
Il y a 7 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created...
-
Quality Manager
Il y a 7 mois
Gent, Belgique Element Materials Technology Temps pleinOverview: We are looking for an experienced **Quality Manager** to join our team and take responsibility for ensuring that our services meet the highest quality standards. You will have a strong background in quality management and a proven track record of implementing and maintaining quality management systems. This includes the quality management system...
-
Quality System Lead
Il y a 7 mois
Gent, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Quality System Lead for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s...
-
Product Quality Manager
Il y a 6 mois
Gent, Belgique Argenx Temps pleinAs part of the Product Quality organization, this function will drive operational quality assurance activities at key vendors for commercial biological drug products and plays a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams. ROLES AND RESPONSIBILITIES: In close collaboration with...
-
Quality Assurance Manager Belgium
Il y a 7 mois
Gent, Belgique BIVMB Temps plein**THE OPPORTUNITY - DO WORK THAT MATTERS** We are seeking a highly motivated Quality professional with GMP expertise to join us as the new **Quality Assurance Manager **at Boehringer Ingelheim Veterinary Medicine Belgium. At BIVMB we focus on the equine mesenchymal stem cells platform, addressing the unmet needs of multiple veterinary patients. In this...
-
Quality Assurance Manager
Il y a 2 mois
Gent, Belgique CERBA RESEARCH NV Temps plein**vacancy_web_description**: As the Quality Assurance (QA) Manager you are responsible to drive and ensure patient safety, data integrity and compliance with the relevant regulations and internal Cerba Research processes covering the clinical laboratory and diagnostic solutions part of clinical trial protocols, in close collaboration with the Scientific and...
-
QA Csv Manager
il y a 1 mois
Gent, Belgique Cerba Research Temps pleinCerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...
-
QA Csv Manager
Il y a 6 mois
Gent, Belgique Cerba Research Nederland Temps pleinCerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...
-
Quality Assurance Manager
Il y a 3 mois
Gent, Belgique Cerba Research Nederland Temps pleinAs the **Quality Assurance (QA) Manager** you are responsible to drive and ensure patient safety, data integrity and compliance with the relevant regulations and internal Cerba Research processes covering the clinical laboratory and diagnostic solutions part of clinical trial protocols, in close collaboration with the Scientific and Project Management...
-
Quality Assurance Manager
Il y a 3 mois
Gent, Belgique Cerba Research Nederland Temps pleinAs the **Quality Assurance (QA) Manager** you are responsible to drive and ensure patient safety, data integrity and compliance with the relevant regulations and internal Cerba Research processes covering the clinical laboratory and diagnostic solutions part of clinical trial protocols, in close collaboration with the Scientific and Project Management...
-
Business System Owner
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinPosition Title: Business System Owner - MES System Location: Ghent - CAR-T For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse...
-
Quality Manager
Il y a 8 mois
Gent, Belgique Synergie Temps plein**Wat zal je job inhouden?**: Ben jij klaar voor een uitdagende rol als Quality manager binnen een chemiebedrijf? Ken je de nodige wetgeving en kwaliteitsnormen? Zou je graag een steentje bijdragen in het opstellen van een kwaliteitsbeleid? Dan ben jij de persoon die we zoeken! Wat zijn je verantwoordelijkheden als Quality manager? - Kwaliteitsnormen...
-
Quality Manager Am Tailored Blank Ghent
Il y a 6 mois
Gent, Belgique ArcelorMittal Temps pleinIntroduction On the ArcelorMittal Ghent site, ArcelorMittal Tailored Blank Ghent produces laser-welded blanks that are used in car body components. What does the job entail? As a Quality Manager you are responsible for the following: - To manage internal quality to fulfill the requirements of all stakeholders (e.g. Repair and release of non-conforming...
-
Quality Assurance Manager Belgium
Il y a 3 mois
Gent, Belgique BIVMB Temps plein**WHO ARE WE?**: At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have...
-
Quality Assurance Manager
Il y a 6 mois
Gent, Belgique Securex Temps plein**Groupe SCX** Depuis plus de 115 ans, Securex aide ses clients et ses employés à briller dans leur vie professionnelle. Chaque jour, nos 1 700 collègues s'engagent à soutenir les entrepreneurs et les employeurs dans leurs activités professionnelles. Nous offrons à ces entrepreneurs et employeurs la gamme de services la plus étendue du marché:...
-
Quality Person
Il y a 6 mois
Gent, Belgique Oxida Temps plein**Quality Person** **OXIDA - 147999** Regio Gent **Wat doe je als Quality Person** - Serves as a Quality person in plant in support of cell therapy manufacturing. - Ensures Quality Oversight in plant covering various process related activities - Performs periodic Quality checks/audits related to process, documentation and process manipulations - Strive to...