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 services.
The Ardena Group is operating from five sites in Europe and one in US. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a
(JUNIOR) QA MANAGER
Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The Quality Assurance group plays a key role in ensuring manufacturing of investigation medicinal products (IMPs), according GMP, with respect of appropriate designed workflows and processes.
YOUR KEY RESPONSIBILITIES
The Quality Assurance Manager is responsible for day-to-day implementation of the Pharmaceutical Quality System in the organization.
* Drafts and keeps up to date the procedures and process flows related to non- sterile as well as sterile manufacturing.
* Provides or supports in training of the personnel for what concerns the Quality processes and GMP awareness.
* Responsible for the daily follow up of the pharmaceutical management system: deviations, changes, CAPAs, complaints, supplier qualification, logbooks, equipment qualification, destructions, shipments, reference and retention samples.
* QA review of equipment and maintenance related documentation.
* QA oversight of Environmental Monitoring in sterile production facility.
* Assists during contractor audits, contract giver audits and performs internal audits.
* Assists the Qualified Person in the preparation of the batch certifications.
* Reviews and approves master and executed (project-related) documents (e.g. Batch Record Documentation, Incoming Material Records).
YOUR PROFILE LOOKS LIKE/ RESEMBLES
* You have a Master degree in Life Sciences (Pharmaceutical Sciences, Biomedical Sciences, (Bio)Chemistry).
* You have knowledge of GMP quality system and regulatory requirements.
* A first experience in Quality Assurance in pharma is a plus.
* You are solution driven, keeping timelines and budget in mind.
* You are continuously looking for improvement.
* You have strong communication skills, able to listen and analyze a quality issue and explaining the proposed solution in an accurate manner.
* You are able to manage the QA support on multiple projects, and like participating in project teams.
* You can express yourself fluently in English.
WHAT WE OFFER
An attractive and tailor-made remuneration package including extra-legal benefits such as meal- and eco vouchers, group- and hospitalization insurance, compensation if you come to work by bike, option for bike lease, etc.
On top of that we offer
* A true learning environment where you will have the ability to grow your skills
* A rapidly International developing and growing company with an interesting services, product and customer portfolio
* A dynamic working environment with nice colleagues
* Open straightforward but also caring culture
* We are true to our values
* Flexible working hours
* 32 days holiday a year