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Post : Quality Auditing Senior Analyst - Pharmacovigilance
Job Description
• Primary responsibility will be to Conduct audits, draft audits reports, approve CAPA responses and track CAPA actions to closure. Quality Management System & Change Management. Comply QMS procedures as per requirement specified in the Quality Manual, applicable Accenture policies and SOPs/Guidance documents. Develop SOP/SWI/Guidance documents for QMS Review SOPs developed by pharma projects. Maintain QA document repository. Review request for changes, perform impact assessment and recommend actions as applicable in compliance with the applicable procedural documents. Review and confirm completeness of documentation for the change request and seek approval. Provide support and guidance as required during client audit / regulatory inspections. Provide support in performing RCA and drafting CAPA responses for Inspections/client Audits and ensure timely closure of CAPAs In this role you are required to do analysis and solving of increasingly complex problems
• Your day to day interactions are with peers within Accenture
• You are likely to have some interaction with clients and/or Accenture management
• You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments
• Decisions that are made by you impact your own work and may impact the work of others
• In this role you would be an individual contributor and/or oversee a small work effort and/or team
• Please note that this role may require you to work in rotational shifts
Candidate Profile
Bachelor of Pharmacy/Master of Pharmacy/Bachelor in Physiotherapy
Additional Information
Experience : 5 to 8 years
Qualification : B.Pharm, M.Pharm
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance & Drug Safety Surveillance
End Date : 20th October, 2023
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