QA Specialist I Review & Disposition
Amsterdam | QA Specialist I | GMP | Batch Record Review | Environmental Monitoring | 1048907
Your new role
As QA Specialist I you’ll be participating in the QA Review and Disposition team, where they review production batch records of intermediates and finished products and prepare the batch file for the QP disposition of Advanced Therapeutic Medicinal Product to the market. Our client’s patients are in high need of their life-saving products, so they work with tight timelines 7 days a week, ensuring their timely delivery.
As QA Specialist I you’ll be participating in the QA Review and Disposition team, where they review production batch records of intermediates and finished products and prepare the batch file for the QP disposition of Advanced Therapeutic Medicinal Product to the market. Our client’s patients are in high need of their life-saving products, so they work with tight timelines 7 days a week, ensuring their timely delivery.
In this role, your responsibilities, amongst others, will be:
- Reviews: both in paper and electronic record format - manufacturing, environmental monitoring and quality control data for in-process and finished products, compiling them as preparations for QA disposition and QP release.
- Identifies and reports deviations or other departures from approved processes and procedures to senior colleagues, whilst also ensuring compliance with applicable regulatory requirements and internal procedures.
- Additional duties as assigned, such as various administrative tasks.
What you’ll need to succeed
The successful candidate should possess a BSc degree (at maximum) with between 2–3 years of relevant pharmaceutical experience working in a cGMP environment.
- Experience working within GMP documentation, batch record reviews, QA archiving would be highly desirable.
- Can successfully and confidently demonstrate solid knowledge of cGMP and GLPs.
- Have familiarity and experience with computerised applications such as LIMS, EBR (Electronic Batch Record) or any ERP system used in accordance with manufacturing record reviews.
- You can demonstrate excellent verbal, written and interpersonal communication skills.
What you’ll get in return
Hays Detachering | This is a project that will start with a contract until the end of the calendar year through Hays. Extension to stay within the department is anticipated, but cannot be wholly guaranteed. In this position, you will get a competitive salary starting from 51,000 annual gross and your travel expenses are covered. There is also a shift allowance provided as compensation for working the odd weekend once a month.
Hays Detachering | This is a project that will start with a contract until the end of the calendar year through Hays. Extension to stay within the department is anticipated, but cannot be wholly guaranteed. In this position, you will get a competitive salary starting from 51,000 annual gross and your travel expenses are covered. There is also a shift allowance provided as compensation for working the odd weekend once a month.
Your new company
Kite, a Gilead company, 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.
Kite, a Gilead company, 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.
With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, Kite is dreaming big. Now you can get the chance to be a part of this journey.
What you need to do now If you are interested in this role as QA Specialist I, 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 on your career.
#LI-DNI
Klik hier om het privacybeleid van Hays te lezen, welke gedetailleerde informatie bevat over hoe we uw persoonlijke gegevens gebruiken en beschermen, en uw rechten in verband hiermee.
Overzicht
- Contractvorm
- Tijdelijk
- Branche
- Wetenschap, Research & Development
- Locatie
- Hoofddorp
- Vakgebied
- Life Sciences
- Salaris
- Salary starts at €51000 annual gross, excl. shift allowance & travel expenses
- Referentie:
- 1048907
Spreek met een consultant
Spreek met Kate Baldwin, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11
Telefoonnummer: +31202361013
JOB_53058111048907