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Visitar feriaSAP Quality and compliance en AstraZeneca
Sueldo oculto
Jalisco
Empleado de tiempo completo
Nivel de Inglés: Nivel Intermedio
onsultant – QCS for a world leading Pharmaceutical company which operates in over 100 countries and is head quartered in the United Kingdom. The candidate is expected to be a part of a process team for a large SAP support and maintenance project, spanning several SAP landscapes across continents.
The candidate should possess broad quality assurance knowledge and good knowledge of computer system validation activities and GxP/SOx regulatory guidelines. The candidate should have proven expertise in supporting large SAP support and maintenance programs as quality assurance representative.
Roles and Responsibilities:
- As a QCS consultant, will be responsible to ensure compliance to Computer System Validation principles & practices in SAP portfolio.
- Responsible for completing all tasks assigned by team lead and project manager.
- Responsible for interacting and guiding functional and technical team members on Computer Validation principles & practices.
- Responsible to ensure all deliverables by the functional and technical teams are as per process documents and any non-compliance is identified and reported within required timeframe.
Required Skills and Experience:
Mandatory:
- Exposure to Computer System Validation activities.
- Ability to perform quality reviews for design documents.
- Experience of reviewing testing document from quality assurance perspective.
- Ability to define and maintain Standard Operating Procedures and quality standards.
- Exposure to compliance issue management and root cause analysis.
- Knowledge of documentation standards and methodology.
- In-depth Knowledge of Pharma GXP regulatory guidelines.
- Understanding of ITIL processes and Application life cycle management.
- Ability to work in large and diverse teams.
- Excellent communication and interpersonal skills.
- Well versed in English. Excellent spoken and written skills.
Desired:
- Experience of Quality approver role as part of change advisory board.
- Supported Wide-ranging regulatory audits.
- Knowledge on IS/IT S404 SOx and FCF controls.
- Exposure to Run SAP (Solution Manager) methodologies.
- Self-motivated, quick learner and admirable team player.
- Desire to improve analytical and validation skills.
- Proactive approach to problem solving.
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