SAP Quality and Compliance

hace 5 días

Guadalajara, México AstraZeneca A tiempo completo

**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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