SAP Quality and Compliance - Guadalajara, México - AstraZeneca
Descripción
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 noncompliance 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.
- Indepth 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 Wideranging regulatory audits.
- Knowledge on IS/IT S404 SOx and FCF controls.
- Exposure to Run SAP (Solution Manager) methodologies.
- Selfmotivated, quick learner and admirable team player.
- Desire to improve analytical and validation skills.
- Proactive approach to problem solving.
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