Qualified person
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 Pharmaceutical organization, based in Zuid-Holland Netherlands.
The client is fully focused on the development of their medicines to improve the health of the patients. They dedicate themselves to providing the most high end quality products. The quality, safety and efficacy of their products is their top priority.
ROLE DESCRIPTION
Do you fit in a organisational culture where integrity, entrepreneurship and flexibility are core competencies? Do you really want to be a essential part of the company? Do you want to make a contribution to the implementation of and maintaining an efficient (c)GMP quality system for biotechnological products? Then this is the job for you!
RESPONSIBILITIES
You will make sure the necessary control functions are executed by review of documentation and by performing audits. Next to that you will become responsible for the legally authorized pharmaceutical release of starting materials, drug substance, drug product and final product manufactured in clinical trials. The following responsibilities will also be your concern:
- Implementation, execution and maintaining document and change control, deviation and inspection management
- Review of batch records, logbooks, scientific reports, policies and procedures
- Release of intermediate and final products
- Auditing contract partners and service providers
- Writing procedures, audit reports and periodic quality oversight reports
REQUIREMENTS
- MSc degree pharmacy or (bio)pharmaceutical sciences
- Knowledge of GMP, GDP, GLP, GCP (GxP)
- Two to three years of experience in (bio)pharmaceutical production, auditing, quality control and/or quality assurance
- Analytical, accurate, pro-active, independent, stress-resistant
- Effective communicator in conversation and writing, in Dutch and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
