Job
Description
Skill required: Quality Governance & Services - Operational Audit & Compliance Designation: Quality Assurance Analyst Qualifications: BE/Bachelor of Pharmacy/Bachelors of Information Technology Years of Experience: Minimum 2 Years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.You will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsThe Operational CSV team focuses on validation of computerized system applications and effective implementation and delivery of functional processes within operations to mitigate risks. The role may require for you to have a good understanding of software tools, GAMP Gudiance, 21 CFR and EU Regulations and hands experience on Validation of Enterprise applications What are we looking for? Information Management System Testing and Validation Adaptable and flexible Ability to meet deadlines Ability to establish strong client relationship Prioritization of workload Problem-solving skills Life Sciences Automation Enablement Life Sciences CSV Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Responsible for supporting and/or conducting validation efforts for Accenture projects. These projects include system implementation, development of non-commercially available systems, deployment of managed hosted systems, validation of systems, and decommissioning of systems. Responsible for project management of the effort. Responsible for authoring or coordinating the authoring of applicable documentation to ensure adherence to current FDA regulations and industry standards: test scripts/checklists (IQ/OQ/UAT), Requirements Specification, Traceability Matrix, System Validation Master Plan, Final Validation Report, etc. Responsible for participating in and contributing to team meetings and fostering knowledge exchange within the Validation Team and with other colleagues. Responsible for mentoring more junior members of the Validation Team. Qualifications BE,Bachelor of Pharmacy,Bachelors of Information Technology
