Quality Release Officer

Oss | Quality Assurance | Release | Validation | Batch record review | CAPA | Investigation | Validation | SAP

Your new role
As a Quality Release Officer, you will serve as a quality advisor for investigators and recommends actions to ensure a state of continued compliance avoiding recurrence. The Quality Release Officer will work with the IPTs/CoE providing guidance in product related GMP questions. You will also review and approve cGMP documents associated to the product in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals. Additionally, you will be responsible for:
  • execution of batch related quality activities
  • providing support to new product activities and improvement to existing products
  • PQR review
  • support identifying the correct metrics and to improve the metrics
  • Owner for QIPT area documents

What you'll need to succeed
In order to be a successful Quality Release Officer, you will need a Bachelor's degree (HLO), preferable in Biotechnology, Chemistry, or relevant field. Experience with quality and compliance guidelines and manufacturing processes. Having knowledge of industry guidance and respective regulations of multiple areas like Production, Validation, Qualification, Quality Assurance, Quality Control, Quality (Management) Systems, Regulatory Affairs, Quality Agreements, Documentation, Inspection and Auditing, are all preferred. As a Quality Release Officer, you need to have strong focus on clients and end-users, ability to work in a team, and a flawless integrity mindset. This position requires excellent interpersonal and communication skills, oral and written (Dutch and English). Experience with documentation system and SAP preferable

Your new company
MSD is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, MSD offers state-of-the-art laboratories, plants and offices that are designed to Inspire their employees as we learn, develop and grow.

In Oss, there are two large production sites that are formerly known as Organon. The first location, Biotech Operations, produces novel biologic active ingredients (“drug substance”). Their activities are split between USP (cell culturing/microbiology in bioreactors up to 22.000 liters) and DSP (filtration and purification of product).The other location, Pharmaceutical Operations, focuses on the production, packaging and distribution of various end products (tablets and injectables) and birth control products.

What you'll get in return
Hays Detachering | This is a project that will start with a contract for 7 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€3200 - €6000) and your travel expenses are covered.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1045701
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Life Sciences
€3500-€6000 per month

Spreek met een consultant

Spreek met Anna-Maria Oikonomou, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telefoonnummer: 0627068392