SAP Quality and compliance en AstraZeneca

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.