Quality Assurance Manager

27/07/21

Location

Kleimoer 4, Gent, Belgium

Function type

QA

Vacancy

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 about 350 professionals operating from 6 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Sweden (Sodertalje), and Latvia (Riga). 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.

To support the expansion of our drug product services with aseptic fill and finish capabilities for the development and clinical production of small and large molecule, injectable formulations, we will extend our DDM Business Unit based in Ghent (Belgium) with a

 

QUALITY ASSURANCE MANAGER

 

WHAT YOU WILL WORK ON

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 sterile manufacturing.

  • Manages the daily follow up of non-conformances (e.g. deviations, changes, CAPAs, complaints).

  • Issues Risk Assessments concerning Quality issues.

  • Evaluates suppliers and manages the approved suppliers' list.

  • Approves protocols for qualification and validation and releases equipment for use in GMP.

  • Reviews and approves master documents (e.g. Batch Record Documentation, Incoming Material Records, Product Manufacturing Records).

  • Reviews and approves executed Batch Record Documentation.

  • Manages the reference and retention samples.

  • Releases new logbooks, reviews logbooks in use, closes completed logbooks.

  • Approves destruction of GMP goods, where required.

  • Verifies shipments of clinical trial-related materials.

 

YOUR PROFILE

  • You have a Master of Science degree in Pharmaceutical Sciences.

  • You have knowledge of GMP quality system and regulatory requirements, in particular in relation to sterile manufacturing,

  • 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.

WE OFFER

  • A true learning environment where you will have the ability to grow your skills

  • A rapidly International developing and growing company with 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

  • An attractive remuneration package

  • Flexible working hours

  • 32 days holiday a year

If you like to have more information about the role, please do not hesitate to contact Stijn Maertens, email: HR@ardena.com, Tel: +32 9 267 65 00

Ready to apply?  Please visit our vacancy on our career page: https://careers.ardena.com/jobs/1265831-quality-assurance-manager

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