Qualified Person Consultant
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands.
The client is one of the world’s leading biotechnology companies which are developing cures and medicines for patients with serious illness.
ROLE DESCRIPTION
This is a project is at least for one year, with a possibility of extension. You will be responsible for providing daily oversight, guidance and support to production staff in regards to compliance with Quality Policies and Procedures.
RESPONSIBILITIES
- Disposition batches labeled 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.
REQUIREMENTS
Minimum Requirements
- 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
Preferred Requirements
- Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
- Customer oriented and service minded
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.
