Description
One of our clients, a multinational in the pharmaceutical industry, currently requires a QA specialist
Location: South of Brussels
Duration: 6 months
Start date: April 2014
MISSION:
-Raises and maintains the status of quality in the organisation and enables a company to promote itself as one that provides quality goods and services. Involves Total Quality Management (TQM) programmes and the development of standard procedures in accordance with GSK standards
and cGMP Regulations.
- 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, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility
* Ensures batches of the intermediate product related to the area of responsibility are released in a timely manner
* Ensures deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner
* Supervises a team of technicians, distributes their work and is responsible for their training and development plan
* Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC
follow-up meetings, ICG project, )
* Ensures critical topics are adequately escalated to higher management
* Acts as QMS subject matter expert (SME) (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements
of the standards are cascaded in SOP's, accountable for gap analysis and related action plans)
* Is the preferred front line spokesperson during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
* Leads local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and standard requirements
* Performs internal and act as external supplier audits
* Understands technical/production complex problems and evaluates potential impact on product quality
* Assesses quality review files and draws adequate conclusions
* Provides QA expertise support to new product introduction projects and related validations
PRE-REQUISITES
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 device environment or equivalent