Junior Quality Assurance Officer
il y a 4 heures
The Product Portfolio Milk Quality & Animal Health (PP MQAH) produces and distributes chemical products by, among others, the Chemicals Division in Drongen (Ghent). The Product Portfolio consists of udder hygiene products, hoof disinfectants and detergents used by dairy farmers around the world.
We are currently looking for a
**Junior Quality Assurance Officer / Qualified Person **for our location in Drongen.
**Job description**
The Junior QA Officer/QP is responsible, together with the QA Manager, for the planning and execution of daily quality assurance activities while ensuring compliance with national and international quality requirements as defined by the applicable guidelines and all existing GMP standards in the area of responsibility. The Junior QA Officer/QP will be performing QA tasks and QP duties for product release of commercial veterinary medicinal products for DeLaval NV (Marketing Authorization Holder). The Junior Quality Assurance officer reports to the QA Manager.
The QP-role is to have permanently and continuously at disposal the services of at least one Qualified Person.
**Delivery of services in this role will include, but not be limited to**:
- **Qualified Person - register & certification**
- Responsible for keeping the release register up-to-date for commercial veterinary medicinal products to be exported to the EU market and outside EU
- Responsible for the batch certification before release for sale or supply or for export
- **Qualified Person - release**
- Responsible for batch review & perform the final batch release in the SAP-system
- Responsible for the adherence of the applicable management system procedures to the batch documents of the commercially produced products
- **QA tasks**
- Collaborate in maintaining and improving the Quality Management System
- Responsible for the validation process
- Participating in and performing internal and supplier audits
- Write, review and approve applicable controlled documentation (reports, procedures, instructions, )
- Deviation, CAPA, Change Control handling: logging, review, approval, execution
- Assess the current GMP compliance status and identify potential gaps
- Participate in the GMP-audit readiness and follow-up
- Back up for QA Manager
- **Others (QA/GMP/GDP intelligence)**
- Ensure relevant knowledge of the manufacturing process to undertake QP duties, this may be by site visits during manufacturing, detailed review of manufacturing batch records, review of customer complaints, review of audit reports, participation in audits as deemed relevant
- Keep up to date with EU directives and local regulations affecting GMP & GDP activities. Ensure the DeLaval NV Quality Department is up-to-date with any changes
- Support other GMP/GDP related worldwide DeLaval sites on GMP/GDP requirements. This can be the Sales organization, Supply Chain or Quality Departments
- Provide input as appropriate on quality issues and QMS. Provides input into quality decisions on critical matters e.g. deviations potentially affecting product quality, safety and efficacy to the QA Manager and to other departments
- Responsible for the risk assessments which may impact the quality of the (released) medicinal products
**Profile**
- Education and degree: a relevant master degree within life sciences : pharmacist, industrial pharmacist
- Registered by the FAGG-AFMPS as Qualified Person (Industrial Pharmacist). Refers to KB 14/12/2006 Art. 211.
- At least 1-2 years professional experience within QA in the (pharmaceutical) industry, GMP production, quality control and GDP
- Working knowledge of Quality Management Systems, GxP, ISO and ICH
**Additional skills**
- Able to give training
- Able to perform audits (internal and external supplier)
- Experience with competent authority inspections
- Experience with validation process
- ISO 9001:2015 knowledge is an asset
- Language knowledge: Fluent in Dutch & English
- Meticulous / eye for detail / well-organised
- Team-player
- Ability to prioritize
**Offer**
Employment contract for an indefinite period
Internal training and opportunities for further development
Attractive remuneration package with extra-legal benefits
Working within a people-oriented international company with an informal, open and driven culture
**Questions about this vacancy?**
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