Specialist – Quality Systems II
Amsterdam |GMP | Quality Systems | HBO + | Documentation | CAPAs & Deviations |+5 years
Specialist – Quality Systems II
Amsterdam |GMP | Quality Systems | HBO + | Documentation | CAPAs & Deviations |+5 years
Your new role:
As a Specialist – Quality Systems II, you support the deployment or management, including training of Quality Systems, in a broad sense. The position allows breakdown into 3 main categories but the specialist interfaces, as compliance partner, with many departments and internal and cross-site stakeholders.
As a Specialist – Quality Systems II, you support the deployment or management, including training of Quality Systems, in a broad sense. The position allows breakdown into 3 main categories but the specialist interfaces, as compliance partner, with many departments and internal and cross-site stakeholders.
- Joint maintenance, site system ownership and training of cross-site procedures such as Change Control, Deviation, MRB (Material review board), CAPA management and Internal Audit.
- Continuous governance and management reporting of site compliance with the quality system's procedures.
- Identification of quality risks in activities and processes according to regulatory agency guidelines and quality policies and procedures.
- Hybrid positions up to 2 days working from home.
Your Responsibilities:
In this role, your responsibilities, amongst others, will be:
In this role, your responsibilities, amongst others, will be:
- Ensuring, at site level or as a member of cross-site quality system committees, Quality Systems' conformance to regulations and quality policies.
- Managing the MRB system (Material review board), administration, communication, and acting as chair of the MRB meetings.
- Managing the Change Control system, support training, administration and participating in multidisciplinary teams associated with the subject.
- Managing the Deviation and CAPA management systems, support training, administration and participating in multidisciplinary teams associated with the subject.
- Supporting coordination of multidisciplinary initiatives as part of our clients' start-up endeavours.
- Ensuring proper maintenance and approval of cGMP documents.
- Reviewing and approving proposed changes to systems and procedures.
- Tracking, reviewing, organising, and reporting metrics and management information for use in continuous improvement and Quality Management Review.
What you’ll need to succeed:
The ideal candidate for this position can demonstrate strong knowledge of GMPs, pharmaceutical law and legislation.
The ideal candidate for this position can demonstrate strong knowledge of GMPs, pharmaceutical law and legislation.
- Experience with Change Control, CAPA, Internal Audit, Deviations, MRB and other ICHQ10 quality systems
- Strong knowledge of aseptic manufacturing processes,
- Proficiency in MS Word, Excel, PowerPoint and Quality management systems.
Education - Bachelor’s degree in a technical discipline (Chemistry/Microbiology/Engineering or similar).
- Required: Minimum of 5 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). Working knowledge of quality systems and regulatory requirements (EU GMPs and ICHQ10),
- Strong written and verbal communication skills in English.
What you’ll get in return:
Hays Detachering | This is a project that will start with a through Hays. Extension to stay within the department is anticipated. In this position, you will get a competitive salary, and your travel expenses are covered.
Hays Detachering | This is a project that will start with a through Hays. Extension to stay within the department is anticipated. In this position, you will get a competitive salary, and your travel expenses are covered.
Your new company:
Our client is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
Our client is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
What you need to do now:
If you are interested in this role as Specialist – Quality Systems II, click ‘Apply now’ to send an up-to-date CV, or give us a call! If this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.
If you are interested in this role as Specialist – Quality Systems II, click ‘Apply now’ to send an up-to-date CV, or give us a call! If this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.
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Overzicht
- Contractvorm
- Tijdelijk
- Branche
- Pharmaceutisch
- Locatie
- Hoofdoorp
- Vakgebied
- Life Sciences
- Salaris
- 59760
- Referentie:
- 1048914
Spreek met een consultant
Spreek met Robbie Wootton, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11
Telefoonnummer: 0202192042
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