Senior Quality Officer – Ardena – Oss

About us

Ardena is a contract development and manufacturing organization for the pharmaceutical industry. We assist pharmaceutical companies, varying 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, dossier development, and bioanalytical services.

Ardena is a rapidly growing, internationally oriented organization with a dedicated team of over 500 professionals operating from six sites in Belgium, The Netherlands, Sweden, Latvia, and Spain. Ardena has an open and transparent culture: team-spirit, an open mindset, and ownership are important values in our company.

As a dynamic CDMO, we offer exciting career opportunities for skilled and motivated people that want to work in a fast-growing business, in the global pharmaceutical industry. The products that Ardena develops for her customers are generally technically highly complex and consequently offer interesting scientific challenges for our team.

The Ardena site in Oss focuses on Drug Substance development and manufacturing services (Business Unit API-NL), Nanomedicines development and manufacturing services (Business Unit Nanomedicines), and Solid State Research (Business Unit SSR).

For the Ardena Business Unit based in Oss, we are looking for aSenior Quality manager.

WHAT YOU WILL WORK ON

The Senior Quality Manager ensures that GMP manufacturing activities on the shop floor and in the analytical laboratory, are executed in accordance with cGMP requirements. He/she adheres to Quality Management System (QMS), is consistent with emerging/existing corporate & regulatory guidelines and contributes to continuous improvement through leveraging the QMS architecture, assuring product quality and safety.

YOUR KEY RESPONSIBILITIES

• Be the QA representative in a global customer project. You will work together with customer, the production team and your colleagues in the QA team in Oss
• Participate in audits from customer and authorities.
• Executing internal and external QA inspections.
• Establish and maintain quality requirements for GMP manufacturing.
• Advising, facilitating, and supporting all phases of manufacturing/analytical batch documentation development.
• Review and approve specifications, methods, batch documentation and risk assessments.
• Release of product.
• Review, approve and follow up on deviations, change controls, CAPA’s and OOS results.
• Write, review, and approve 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 Bachelor’s degree, with pharmaceutical, chemical or other relevant training.
• At least 5 years relevant experience in the pharmaceutical industry.
• Experience and good knowledge quality management systems like cGMP, ISO.
• Experience in providing GMP trainings.
• Pragmatic attitude.
• Able to apply phase-appropriate GMP principles in the process development trajectory.
• You feel comfortable in a dynamic and changing environment
• 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
• Plus: Experience with GAMP and 21 CFR Part 11 is preferred and computerized system validation

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

Do you have questions?

For questions please contact Jeroen Geeven, Director Quality Assurance

jeroen.geeven@ardena.com

+31(0)6 51699242

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.

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