Vacancy for a Qualified Person
Full time position
At Glycostem we are recruiting a Qualified Person (QP).
The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role. The basic responsibility is to ensure that our cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs.
As QP you provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.
You will work in an innovative, fast growing, biotechnology company and will report to the Chief Regulatory/Quality Officer with the obligatory dotted line into the CEO.
Roles and responsibilities for our Qualified Person are described in Article 51 of Directive 2001/83/EC, and can be summarised as follows:
- The QP is responsible for ensuring that each individual batch has been manufactured and tested in accordance with the requirements of the IMPD and the applicable GMP regulations.
- The QP is responsible for batch disposition (e.g. GMP-release) of the batches produced.
- The QP is involved in the set-up and validation of the manufacturing process, analytical methods and specifications.
In addition to the QP role and responsibility the QP will help and assist with:
- Document control
- Deviation and CAPA system management
- Product complaints, returns, and recalls
- Vendor approval, qualification and management
- Internal (self-inspections) / external audit program
- Quality / technical agreements
- Batch record reviews
- Change management / change control
Education, skills and experience
- M.Sc. or PhD degree in pharmacy, biotechnology, biology or equivalent
- Experience in QP-related functions
- Experience working in a GMP regulated environment
- Experienced in biotech products where experience with Advanced Therapy Medicinal Products (ATMPs) is preferential
- Knowledge of biotech production processes
- Knowledge of sterile production processes
- Knowledge of GMP quality systems
- After a successful trial period a permanent contract is extended.
- Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication;
- Pension premium contribution;
- Travel allowance or public transport reimbursement;
- 25 holidays.
Do you have what it takes?
Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.
Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.