Max. € 80
Detachering via YER
Medical & Health
Over deze vacature
We are looking for a QA Specialist - QP. The Product Quality & Compliance group is part of the company organization. As a Specialist QA/QP, you will report into the Senior Manager QA/Head QP. The product Quality & Compliance team consists of 3 people. On a daily basis you will interact with numerous stakeholders located both in Breda as internationally.
Preferably you have had your first experience as a QP or alternatively you have a few years of experience in Quality Assurance and have the qualifications to become a QP. You are able to maintain oversight on different projects, dive into details when required and provide Quality guidance to other functions. Working in teams and communicating effectively with all kind of stakeholders is crucial in this role.
- Provide daily oversight, guidance and support to Production staff in regards to compliance with Quality Policies and Procedures
- Disposition batches labelled and packaged at ABR
- Handle Non Conformances and CAPA’s mainly as initiator or QA-contact. Lead and assist in various investigations as needed
- Own, review and approve SOP’s
- Handle change control records mainly as assessor or as QA contact
- Participate in ABR projects and improvement efforts including product launch teams
- Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements
- Perform GMP compliance checks in production
- Assist in development and delivery of GMP training activities for QA- and production staff
The company leading in the field of human medicine in the biotechnology industry. For over 30 years, the company has expanded the power of scientific discoveries and innovations to significantly improve people's lives.
The company pioneered the development of new products based on advances in recombinant DNA and molecular biology and launched the first blockbusters in the biotechnology industry. At the moment, a Fortune 500 company, is committed to millions of patients, an enterprising, science-based company dedicated to helping people fight serious diseases.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
- EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
- Typically 3+ years of related professional experience, relevant experience in dealing with non-conformances and change control records
- Good problem solving skills
- Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
- Experience in (bio) pharmaceutical production environment, in particular packaging and labelling
- Customer oriented and service minded