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QA Coordinator
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
Our client, a world leading pharmaceutical company, is currently looking for a QA COORDINATOR for a long-term assignment.
Duration: long term
Location: Walloon Brabant
Responsibilities:
The QA COORDINATOR 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. S/He involves TOTAL QUALITY MANAGEMENT (TQM) programmes and the development of standard procedures in accordance with quality 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
* Ensures quality oversight of all activities related to the 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
* Ensures critical topics are adequately and timely escalated to higher management
* Represents QA in all operational meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow-up meetings, )
* Supervises a team of technicians, distributes their work and is
responsible for their training and development plan
* Performs internal audits
* Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with CGMP and standard requirements
* Provides QUALITY ASSURANCE support to new product introduction projects and related validation activities
* Understands technical/production problems and evaluates their potential impact on product quality. Escalates complex problems to N+1
* Compiles quality reviews
Requirements:
* Scientific university degree (Pharmacist, Engineer or equivalent)
* Very good knowledge of English
- Very good knowledge of English
* Knowledge of GMP regulated environment
- Minimum 2 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
TAGS: QA, QUALITY ASSURANCE, CGMP, GMP, CAPA
Duration: long term
Location: Walloon Brabant
Responsibilities:
The QA COORDINATOR 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. S/He involves TOTAL QUALITY MANAGEMENT (TQM) programmes and the development of standard procedures in accordance with quality 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
* Ensures quality oversight of all activities related to the 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
* Ensures critical topics are adequately and timely escalated to higher management
* Represents QA in all operational meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow-up meetings, )
* Supervises a team of technicians, distributes their work and is
responsible for their training and development plan
* Performs internal audits
* Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with CGMP and standard requirements
* Provides QUALITY ASSURANCE support to new product introduction projects and related validation activities
* Understands technical/production problems and evaluates their potential impact on product quality. Escalates complex problems to N+1
* Compiles quality reviews
Requirements:
* Scientific university degree (Pharmacist, Engineer or equivalent)
* Very good knowledge of English
- Very good knowledge of English
* Knowledge of GMP regulated environment
- Minimum 2 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
TAGS: QA, QUALITY ASSURANCE, CGMP, GMP, CAPA
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges