- Ensuring compliance to Computer System Validation principles & practices in SAP portfolio.
- Completing all tasks assigned by team lead and project manager.
- Interacting and guiding functional and technical team members on Computer Validation principles & practices.
- Ensuring all deliverables by the functional and technical teams are as per process documents and any non-compliance is identified and reported within required timeframe.
- 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.
SAP QCS Associate Application Engineer - Guadalajara, Jal., México - AstraZeneca GmbH
Descripción
SAP QCS Associate Application Engineer
About the AstraZeneca
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Welcome to Guadalajara one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day. To help you maintain your best self, here's a sneak peek into some of the things this site provides for you.
About The role
Become a SAP QCS Associate Application Engineer 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.
The SAP QCS Associate Application Engineer will be accountable for:
Requirements
Essential
Desirable
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Interested? Come and join our journey.
So, what's next
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
Where can I find out more?
Our Social Media:
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AstraZeneca is an equal opportunity employer.
AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Strong English communication skills required.
Positions are open to Mexican Citizens and official residents of Mexico.
Location: Guadalajara (hybrid - Expectation of working in the office 3 days a week)
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.