(Junior) Quality Assurance Manager
il y a 5 heures
**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 seven sites in Europe. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a
**(JUNIOR) **QUALITY ASSURANCE MANAGER**
**YOUR KEY ROLE**
**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.
- 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 documents (e.g. Batch Record Documentation, Incoming Material Records, Product Manufacturing Records).
**YOUR PROFILE**
- You have a Master degree in Pharmaceutical Sciences.
- 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.
**WE OFFER**
- An attractive and tailor-made remuneration package including extra-legal benefits such as
- Compensation if you come to work by bike
- Daily meal vouchers
- Group/hospitalization insurance
- Flexible working hours
- 32 days holiday per year
- Ability to grow your skills in a rapidly growing company with international customer portfolio
- A dynamic working environment
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