qa operational - 98234.

Functional area :

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. lnvolves Total Quality Management (TQM) programmes and the development of standard procedures

Discipline :

Develops, assures and maintains the quality of the product and processes

• Standard procedures
• Quality audits/review
• Key Performance lndicators (KPls)
• Process re-engineering

Key responsibilities :

• 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
• Ensures critical topics are adequately escalated to higher management
• Acts as QMS subject matter exped (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 expeÉise 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
• 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
• Management of technicians' team
• Supports the "Coordinator QA" for critical topics
• Represents QA and takes decisions in his/her area of responsibility
• QMS subject matter expert (SME)
• First contact during inspection for the subject of expertise
• Leads local and/or transversal improvement projects
• Performs internal audits and act as external supplier auditor
• Understands technical/production complex problems and evaluates

• Scientific university degree (Pharmacist, Engineer or equivalent)
• Very good knowledge of English
• Knowledge of GMP regulated environment
• Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
• Takes action to monitor and control costs within own work area
• Manages own time to meet agreed short-term targets
• Ensures the coherence between contributions / quality of final results and procedures, encourages reflection on the need to adapt/align procedures; may propose new operating procedures

Consultancy

We offer an attractive salary with extra-legal advantages : 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible