Job Description :
Role Name: Quality Manager
City | Location: TCS - Iselin, NJ(South) | Peapack |Peapack, NJ
Duration (Months): Long Term.
Competencies:
Healthcare: Pharma, HP Quality Center (Mercury), Assurance : Test Management, BPS : Pharmacovigilance
Essential Skills:
Experience in Pharma is a must
Functional Experience in Pharmacovigilance, regulatory documentation , case review
Certification in Drug safety and Pharmacovigilence
Experience with Individual case safety reports (ICSRs)
Experience with WHO Drug dictionaries and signal management tools
Understanding of signal detection and managemnt process
Experience of working with GxP systems
Understanding in QA, Requirement Analysis, Team Management, Planning, Estimations, Scheduling
Experience in quality assurance/development/support of Pharmocovigilence applications and clinical studies
verification of E2B R2/R3 conversions within Argus Safety
Understand Argus back end tables enough to query and BO enough to pull objects and check output
Comfortable with Backend SQL to help confirm that the objects are working appropriately
Role Description:
Strengths should include functional knowledge of various PV systems
Serve as PV SME for computer system validation
client interactions, handling teams, project planning and co-ordination of team in varied geographies.
Work with Development, testing and support team and provide them guidance as a PV SME
Used Toad for Oracle to verify database content as part of the testing process.
Excellent oral and written communication as well as analytical and interpersonal skills.
Validation lead for drug safety applications (including Argus Safety) for major pharmaceutical company.
Review test execution results to ensure compliance with documented SDLC and GxP for validated systems.
Experience with client facing consulting engagements
Support in Test Planning, Testing Effort Estimation and Test strategy creation.
Architect test strategy based on PV system knowledge
Execution of test scripts and reporting using HP ALM.
Defect tracking, defect review, validation and root cause analysis.
Should have work on Agile and Scrum methodologies.
Experience within a delivery role
Experience with client facing consulting engagements.
Knowledge of Pharma domain would be an added advantage.
Desirable Skills:
ALM Knowledge, test automation
And also provide the VISA Copy And ID proof for the submission.