SAP Quality and compliance en Zapopan, Jalisco para AstraZeneca - Hireline México

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SAP Quality and compliance en AstraZeneca

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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:


  • 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.


  • 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.