QA Manager Qualification and Validation
2 maanden geleden
**QA Manager - Qualification and Validation (QVM)**
Solvias NL, part of the international Solvias Group, is a fast-growing biotech Contract Research Organization (CRO) located at the Utrecht Science Park. We are a leading provider of high-end genetic Quality Control solutions in the fields of cell-line development, cell and gene therapy, and transgenic models, worldwide. It is our mission to improve the quality and safety of genetic research and human healthcare.
Currently, we are looking for an enthusiastic, all round **QA Manager - Qualification and Validation (QVM), **to support the growth and ambitions of our company, to maintain ISO/IEC17025 accreditation and obtain a GMP license.
You will be joining the QA team, currently consisting of 2 QA managers and 1 QA officer, led by the Head of QA.
**Tasks and Responsibilities of the QVM**
- Ensures proper qualification of equipment/instruments/computerized-systems and method validation/transfer/qualification/verification by guaranteeing adherence to the corresponding regulation requirements.
- Ensures proper re-qualification and Maintenance SOPs.
- Ensures proper Analytical Test Method descriptions are in place.
- Support in Feasibility & Robustness studies in Method Design.
- Advises on preparation of URS, DQ and IQ/OQ/PQ and Tech Transfer documents.
- Acts as first QA contact for equipment (re-)qualification.
- Ensures compliance activities including but not limited to releasing method validation, Tech Transfer, Qualification and Verification documents and to assigning GMP status of equipment initial (re)qualification in relation to supplier qualification, changes, CAPAs, audit observations and vendor change notifications.
- Ensures proper qualification of Assay & Product Development (A&PD) and Software Development & Bioinformatics (SD&BI) departments by supervising adherence to GMP requirements.
- Support in deviations management, CAPA and continuous process improvement in the departments of A&PD and SD&BI.
- Contribute to Customer and Third-Party audits as Subject Matter Expert for Qualification, Validation and Tech Transfer.
- Act as back up for QA managers when needed.
**We are looking for a QVM who...**
- >4 years working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance.
- Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems.
- Solid know-how in EU and US GMP regulations relevant for computerized systems validation à GAMP5.
- Excellent communication and decision-making skills.
- Ability to provide solutions for complex challenges and work independently in a team environment.
- Solution oriented, precise, organized.
- Good inter-personal skills.
- Energized and open-minded.
- Willingness to learn and carry out new and complex tasks.
- Proactive attitude.
- Excellent knowledge of written and spoken English.
**What we offer**
Working at Solvias means working in an international and exciting environment. We are a young and dynamic team of talented people from all over the world. Our company culture is best described as informal - where hard work and team spirit are considered very important.
We offer an exciting and dynamic 0.8-1 FTE job in a vibrant, fast-growing company with an excellent remuneration and opportunities for further personal development.
**Are you interested?**
Soort dienstverband: Fulltime, Parttime
Verwacht aantal uur: 32 - 40 per week
Aanvullende vergoedingen:
- Vakantiegeld
Arbeidsvoorwaarden:
- Pensioen
- Reiskostenvergoeding
Werkschema:
- ma-vr
Werklocatie: Hybride werken in 3584 CM Utrecht
Deadline sollicitaties: 30-10-2024
Verwachte startdatum: 01-11-2024
-
QA Architect
5 dagen geleden
Utrecht, Nederland Kramp GmbH VoltijdWould you like to be be responsible for shaping and driving the QA vision which includes driving and improving the test automation and performance strategies? We are looking for a **QA Architect** who will be setting the methodologies and technical directions for new Quality Assurance initiatives. You will support and guide our QA automation engineers and...
-
Senior Manager, QA GCP/PV
6 maanden geleden
Utrecht, Nederland Genmab VoltijdThe Role & Department Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and...
-
Senior Quality Engineering Architect, Test
6 maanden geleden
Utrecht, Nederland Genmab VoltijdThe Role As a Quality Engineering Architect at Genmab, you will be instrumental in designing, implementing, and leading all aspects of the validation and testing architectures for our extensive portfolio of research and clinical development platforms. This includes but is not limited to Laboratory Information Management Systems (LIMS), Electronic Lab...
-
Senior Manager, QA GCP/PV
6 maanden geleden
Utrecht, Nederland Genmab VoltijdThe Role & Department Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and...
-
Silcon Validation Engineer
1 maand geleden
Utrecht, Utrecht, Nederland Qorvo VoltijdJob Title: Silcon Validation EngineerAbout the Role:We are seeking a skilled Silcon Validation Engineer to join our team at Qorvo. As a Silcon Validation Engineer, you will be responsible for developing, implementing, and executing automated tests focused on validating the performance and robustness of Qorvo IoT devices.Key Responsibilities:- Measuring RF...
-
Senior QA Engineer
3 weken geleden
Utrecht, Utrecht, Nederland SurePay VoltijdAbout the RoleWe are seeking a highly skilled Senior QA Engineer to join our team at SurePay. As a Senior QA Engineer, you will be responsible for developing and implementing quality assurance strategies, testing, and delivering high-quality software products. Key Responsibilities- Design and implement test automation frameworks and test architecture...
-
Associate Director, QA GCP/PV
6 maanden geleden
Utrecht, Nederland Genmab VoltijdAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
QA Automation Lead
6 maanden geleden
Utrecht, Nederland JWP Voltijd**About JWP**: JWP is transforming the Digital Video Economy as a trusted partner for over 40,000 broadcasters, publishers, and video-driven brands through our cutting-edge video software and data insights platform. JWP empowers customers with unprecedented independence and control over their digital video content. Established in 2004 as an open-source video...
-
System Compliance Manager, Digital Systems Management, Veeva Vaults
6 maanden geleden
Utrecht, Nederland Genmab VoltijdAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Manual QA Engineer Intern
3 weken geleden
Utrecht, Utrecht, Nederland FonQ VoltijdWe are seeking a detail-oriented and motivated Manual QA Engineer to join our quality assurance team. This role is ideal for someone eager to gain practical experience in software testing. As a Manual QA, you will work closely with our development and business stakeholders to help ensure our products meet the highest standards of quality.About fonQ fonQ is a...
-
Senior QA Engineer
1 maand geleden
Utrecht, Utrecht, Nederland SurePay VoltijdJob Description:At Sure Pay, we're seeking a skilled Senior QA Engineer to play a pivotal role in ensuring the highest standards of software quality and performance. As a key member of our Agile team, you'll be responsible for developing and implementing quality assurance strategies, testing, and collaborating with developers and DevOps engineers to deliver...
-
Product Visionary and Agile Leader
3 weken geleden
Utrecht, Utrecht, Nederland Brainboss B.V. VoltijdBrainboss B.V. is seeking a seasoned Product Owner to drive product vision and strategy for our teams.The ideal candidate will possess a deep understanding of Agile Scrum methodologies and excellent communication skills in both English and Dutch.Job DescriptionWe are looking for a highly skilled Product Owner who can bridge the gap between business...
-
Clinical Data Manager
3 maanden geleden
Utrecht, Nederland Yacht VoltijdYacht Life Sciences has an opportunity for aClinical Data Manager at an International Food Innovation Company situated in Utrecht, the Netherlands. As a Clinical Data Manager, you will be a member of the Human Evidence Data Operations team, which is part of the Human Evidence and Insights Generation department. As a Clinical Data Manager you are responsible...
-
Marketing and Admissions Manager
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdJob Title: Manager, EMBA Marketing and AdmissionsJob Summary: HKU invites applications for Manager, EMBA Marketing and Admissions, to lead the marketing and admissions functions for Executive MBA programmes.Key Responsibilities:Develop and implement effective marketing strategies to promote the EMBA programmeCoordinate admissions processes, including...
-
Manufacturing Engineering Manager
1 maand geleden
Utrecht, Utrecht, Nederland ViCentra VoltijdAbout the RoleThe Manufacturing Engineering Manager will play a pivotal role in leading and supporting the Manufacturing Engineering Team focused on sustaining and improving our internal manufacturing processes, equipment, and facilities. The overall goal of the Manufacturing Engineering Team is to ensure that our internal manufacturing lines producing...
-
Manager and Assistant Manager
6 maanden geleden
Utrecht, Nederland HKU VoltijdManager and Assistant Manager (Marketing and Branding) (at the rank of Administrative Assistant II and Executive Officer) (2 posts) in the Communications and Public Affairs Office of the Registry (Ref.: 524238) (to commence as soon as possible, on a two-year fixed-term basis with contract-end gratuity and University contribution to a retirement benefits...
-
Data Analyst Internship
2 weken geleden
Schiphol-Oost, Nederland Perfetti Van Melle VoltijdPerfetti Van Melle is one of the world's largest manufacturers and distributors of confectionery and chewing gum, with a presence in over 150 countries. Our Company Overview showcases our commitment to innovation and customer satisfaction.Job DescriptionWe are seeking a talented Data Analyst Intern to join our Group Business Intelligence team for a minimum...
-
Groundwater and Geochemistry Data Manager
2 weken geleden
Utrecht, Utrecht, Nederland TNO VoltijdCompany OverviewTNO is a leading research organization in the Netherlands, focused on developing innovative solutions for various industries.About the RoleWe are seeking a skilled Groundwater and Geochemistry Data Manager to join our team at TNO. In this position, you will be responsible for managing large datasets related to groundwater and geochemistry.Job...
-
Quality Assurance Tester
1 week geleden
Utrecht, Utrecht, Nederland fonQ VoltijdWe are seeking a detail-oriented and motivated Manual QA Engineer Intern to join our quality assurance team. This role is ideal for someone eager to gain practical experience in software testing.As a manual QA intern at fonQ, you will work closely with our development and business stakeholders to ensure our products meet the highest standards of quality.fonQ...
-
Marketing Manager
2 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdHKU Communications and Public Affairs OfficeWe are seeking a Marketing Manager - Events and Engagement to join our team.About the RoleThe Marketing Manager - Events and Engagement will be responsible for developing and executing effective events, marketing strategy, and community engagement plans to promote University initiatives. This includes planning,...