Risk and Compliance Senior Analyst

Job Description

Skill required: Risk & Compliance - Internal Audit Quality Assurance Designation: Risk and Compliance Senior Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy/Bachelor in Physiotherapy Years of Experience: 7+ years What would you do? Prepare and Conduct audits, complete the checklists in the eQMS, draft audit reports, approve CAPA responses and track CAPA actions to closure. Perform vendor audit. Provide support and guidance as required during client audit / regulatory inspections. Support in performing annual internal audit plan and quarterly reconciliation of annual audit plan. Comply with QMS procedures as per requirement specified in the Quality Manual, applicable Accenture policies and SOPs/Guidance documents. Develop procedural documents SOP/SWI/Guidance documents for QGO in consultation with the QGO Lead or designee.You will be working as a part of the Quality Governance Organization team which is responsible for performing quality audits.You will be responsible for internal audit and vendor audit majorly for clinical data management. What are we looking for? Clinical Data Management Clinical eTMF Management Clinical EDC Build Quality Assurance (QA) Quality Auditing Ability to meet deadlines Ability to perform under pressure Adaptable and flexible Agility for quick learning Commitment to quality Roles and Responsibilities: Prepare and Conduct audits, complete the checklists in the eQMS, draft audit reports, approve CAPA responses and track CAPA actions to closure. Perform vendor audit. Provide support and guidance as required during client audit / regulatory inspections. Support in performing annual internal audit plan and quarterly reconciliation of annual audit plan. Comply with QMS procedures as per requirement specified in the Quality Manual, applicable Accenture policies and SOPs/Guidance documents. Develop procedural documents SOP/SWI/Guidance documents for QGO in consultation with the QGO Lead or designee. Qualifications Bachelor of Pharmacy,Master of Pharmacy,Bachelor in Physiotherapy