Description
For one of our clients working in the pharmaceutical industry, we arecurrently looking for a QA Specialist
Start: ASAP
Lenght: 30/4/13 + possible extension
Location: South of Brussels
Functional Area:
Raises and maintains the status of quality in the organisation andenables a company to promote itself as one that provides quality goodsand services. Involves Total Quality Management (TQM) programmes andthe development of standard procedures in accordance with clientsstandards and cGMP Regulations.
Discipline:
Develops, assures and maintains the quality of the product and processes
- Standard procedures
- Quality audits/review
- Key Performance Indicators (KPIs)
- Process re-engineering
Key accountabilities:
* Masters the key QA activities related to production, QC, maintenanceand calibration, warehouse, CSV, validation, project activities is/her area of responsibility
* Ensures batches of the intermediate product related to the area ofresponsibility are released in a timely manner
* Ensures deviations, complaints, change controls, OOS investigation,maintenance and calibration plans are reviewed and handled in a timelymanner
* Supervises a team of technicians, distributes their work and isresponsible for their training and development plan
* Represents QA (decision responsibility) in all meetings related tothe area of responsibility (staff meetings, deviation, CAPA, RPCfollow-up meetings, ICG project, )
* Ensures critical topics are adequately escalated to higher management
* Acts as QMS subject matter expert (SME) (= knowledgeable of the QMSstandard related to the area of expertise, ensure all requirements ofthe standards are cascaded in SOP's, accountable for gap analysis andrelated action plans)
* Is the preferred front line spokesperson during inspection for thesubject of expertise as well as for all operational aspects belongingto the area of responsibility
* Leads local and/or transversal improvement projects to ensure thecompliance level is maintained in line with cGMP and the clientsstandard requirements
* Performs internal and act as external supplier audits
* Understands technical/production complex problems and evaluatespotential impact on product quality
* Assesses quality review files and draws adequate conclusions
* Provides QA expertise support to new product introduction projectsand related validations potential impact on product quality
- Provides QA expertise support to new product introduction projects
Education:
* Scientific university degree (Pharmacist, Engineer or equivalent)
Knowledge:
* Very good knowledge of English
* Knowledge of GMP regulated environment
Experience:
* Minimum 5 years of experience in a Pharmaceutical/Bio/Medical deviceenvironment or equivalent