QA Officer
About us
Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
Ardena is a rapidly growing international orientated organization with a dedicated team of over 500 professionals operating from 5 sites in Belgium, The Netherlands, Sweden and Spain. Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.
We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.
For the Ardena Business Unit based in Oss, we are looking for a QA Officer
WHAT YOU WILL WORK ON
The Quality Officer ensures that GMP manufacturing activities on the shop floor and analytical activities in the laboratory, are executed in accordance with cGMP requirements. He/she adheres to the Q uality Management System (QMS).
YOUR KEY RESPONSIBILITIES
- Releasing raw materials and chemicals for production and analytical activities
- Send and review questionnaires for material supplier and service provider qualifications
- Maintaning supplier/service provider qualifications
- Participate in audits from customer and authorities.
- Executing internal QA inspections, Walk Through Audits
- Maintaining and controlling document management
- Maintaining and controlling QA inbox
- Evaluate batch record review reports
- Write, review, and approve procedures and instructions.
- You feel comfortable in a dynamic and changing environment
- No personnel responsibilities are included in the role
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- At least a MBO (Secondary vocational education) degree, with pharmaceutical, chemical or other relevant training.
- At least 3 years relevant experience in the pharmaceutical industry.
- Experience and good knowledge quality management systems like cGMP, ISO.
- Pragmatic attitude.
- You like to learn and develop yourself
- You are flexible, a problem solver and a team player
- You have an analytical mindset and you are stress resistant
- You have good communication skills and are fluent in Dutch and English (written as well as spoken).
- We love creative thinking and pro-activeness
WHAT WE OFFER
- A true learning environment where you will have the ability to grow your skills
- A rapidly developing and growing international company with an attractive services, product and customer portfolio
- A dynamic working environment with nice colleagues
- Open straightforward but also caring culture
- We are true to our values
- An attractive remuneration package
- Flexible working hours
- 30 days holiday a year
- Fruit & Fitness possibilities
Ready to apply? Please click on the application button
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.
- Department
- Quality Assurance
- Role
- QA Officer
- Locations
- Oss
Colleagues
Oss
QA Officer
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