Job Title:Senior Consultant - SAP QCS 
Location:TRIL GTC Chennai
GCL: D2

Job Summary:

Senior Consultant – QCS for a world-leading Pharmaceutical company which operates in over 100 countries and is headquartered 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 a quality assurance representative.

Job Description:

Roles and Responsibilities:

• As a QCS senior consultant will be responsible to ensure compliance with Computer System Validation principles & practices in the SAP portfolio.
• Responsible for finishing the tasks assigned by team lead and project coordinator.
• Responsible for the completion of the AdHoc initiatives they are assigned.
• Responsible for interacting and guiding functional and technical team members on Computer Validation principles & practices.
• Responsible to ensure all results by the functional and technical teams are as per process documents and any non-compliance is identified and reported within the required timeframe.
• Responsible to ensure that the data for the QCS monthly reports are sent on time.
• Responsible for mentoring the junior members of the team on QCS activities.

Required Skills and Experience:

Required:

• Exposure to Computer System Validation activities.
• Ability to perform quality reviews for design documents.
• Experience in reviewing the testing document from a quality assurance perspective.
• Ability to define and maintain SOPs 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.
• Superb communication and interpersonal skills.
• Well versed in English. Excellent spoken and written skills.
• Willingness to work in shifts.
• Experience of Quality approver role as part of the change advisory board.
• Supported Wide-ranging regulatory audits.

Desired:

• Knowledge on IS/IT S404 SOx and FCF controls.
• Exposure to Run SAP (Solution Manager) methodologies.
• Self-motivated, quick learner and an admirable standout colleague.
• Zeal to improve analytical and validation skills.
• Experience working in a globally distributed team.
• A proactive approach to problem-solving.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.