Skill required: Risk & Compliance - Internal Audit Quality Assurance
Designation: Risk and Compliance Specialist
Qualifications:Bachelor of Pharmacy
Years of Experience:7 to 11 years
Language - Ability:English - Expert
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? Overall Purpose of the job To implement and comply with Quality Management System (QMS) and Audit & Inspection management processes across pharma projects. You will be aligned with our Risk and Compliance vertical and help us perform compliance reviews, publish reports with actions and provide closure guidance as needed. We design & recommend effective controls to mitigate risks and help service delivery team prepare for upcoming client / external audits. • Audits & Inspections: Develop the Audit Schedule for the Fiscal year in agreement with the QGO Lead • Schedule and conduct audits, release/draft audits reports, approve CAPA responses and track CAPA actions to closure. • Monitor compliance to the audit schedule • 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 for Inspections/client audits. Highlight risks and take appropriate actions (as required) in consultation with QGO Lead/designee. • Quality Management System (QMS) & Change Management: Implement/comply QMS procedures as per requirement specified in the Quality Manual, applicable Accenture policies and SOPs/Guidance documents. • Develop SOP/Guidance documents for QGO • Review Standard Operating Procedures (SOP)/ /Guidance documents developed by pharma projects. • Maintain QA document repository. • Provide training to pharma projects on GxP requirements. • 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.
What are we looking for? •Pharmacovigilance & Drug Safety Surveillance - PV, ICSR, Auditing experience must •Internal Audit Quality Assurance •Operational Audit & Compliance •Commitment to quality •Ability to manage multiple stakeholders •Ability to perform under pressure •Collaboration and interpersonal skills •Prioritization of workload •Risk Management •Quality Assurance (QA)
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems • May create new solutions, leveraging and, where needed, adapting existing methods and procedures • The person would require understanding of the strategic direction set by senior management as it relates to team goals • Primary upward interaction is with direct supervisor • May interact with peers and/or management levels at a client and/or within Accenture • Guidance would be provided when determining methods and procedures on new assignments • Decisions made by you will often impact the team in which they reside • Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture • Please note that this role may require you to work in rotational shifts
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