In this role you will be responsible for validation and product registration activities of assigned drug products. You will work in cross-functional teams with different departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site. You ensure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations (GMP, ICH, ..) and with the description in the submitted registration dossiers.
To accomplish the above:
You perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations. In this quality authority role you will work closely together with different project teams and different departments as well as with R&D.
You support regulatory submissions of the products by informing site colleagues of regulatory requirements and by providing the project details and the supporting validation data to GCMC. In this regulatory role you work closely together with global regulatory colleagues and R&D.
You coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.
AKKA is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, aerospace, rail, space, defense, energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies
With more than 22.000 experts in over 25 countries, AKKA is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.
Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience or interest in validation, regulatory and quality.
Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset.
Insight and understanding of shareholders needs and requirements.
Takes initiative and ownership to deliver on time without compromising on quality
Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation)
Fluent in written and spoken English and Dutch
As an AKKA consultant, you will be:
In charge of diverse transversal and empowering projects
Supported in your career by your AKKA Manager
Actor of your training plan and your personal and professional development
Member of a dynamic and collaborative community of engineers
Benefiting from a permanent contract
Benefiting from a competitive salary packages including several extra-legal benefits.