Job Title

Senior Analyst - Quality Assurance

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Job Description

Competencies:
In-depth knowledge and hands-on experience with Computer System Validation Principles as it applies to IT systems in the Life sciences industry
Must be proficient in QMS methodology, Good Documentation Practices, Good Testing Practices, Change Management Processes, Risk Management, Failure Deviation and Issue Management, Computer System Validation, 21 CFR Part 11
To coach the project teams on Validation approach and support resolving conflicts
Should be capable of handling multiple projects
Must be Quality Conscience
Excellent communication and interpersonal skills in order to talk to customer’s Compliance department Heads and Managers
Work towards achieving company objectives and drive the team to achieve these goals
Must be a good team player and Customer satisfaction focus

Preferred Skills
Minimum 4 to 7 Years of experience in computer system validation
Understanding of Standards and Guidelines like GAMP that are applicable to IT systems and platforms used for business-critical operations in life sciences set-up·
Understanding of SDLC Lifecycle and Validation
Thorough understanding of fundamentals and various aspects of Quality Management systems and Computerized system validation
Co-ordination with Cross Functional Teams
 
Roles and Responsibilities:
Moderating Deviations and escalations with respect to CSV Process and Validation deliverables
Reviewing Testing Protocols and Summary Reports
Reviewing Validation Plan and Summary Reports
Responsible for ensuring the quality of all the deliverables from services delivered during project implementation and Pre-validation
Closely working with customer quality/compliance function to address their queries and concerns
Involved in Defect Management Lifecycle and Work on Test Management Tools
On need basis, involve in Periodic review of Tool and tool qualification
Audit process compliance as per annual audit calendar
Periodic reports to highlight weak areas (Risks) for improvement and good practices
Participate in conducting in process audits and training as required

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