Quality Assurance Specialist - Life Sciences & Pharmacovigilance

Quality Assurance Specialist

Skill required: Quality Governance & Services - Operational Audit & Compliance
Designation: Quality Assurance Specialist
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:7 to 11 years
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 784,000 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? "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. Quality Governance & Services involves setting and enforcing standards to ensure the quality of products or services. This includes developing quality policies, conducting audits, and ensuring compliance with industry regulations. The goal is to maintain high standards and consistency in service delivery. Effective quality governance helps in reducing errors, improving customer satisfaction, and enhancing overall performance. It is crucial for maintaining trust and reliability in an organization. Audit and manage effective implementation and delivery of functional processes within operations to mitigate risk. e.g. Policies; Anticorruption, BCM, InfoSec, P104, Records Management and Contractor controls. Establish processes to audit/validate current control effectiveness and drive improvements wherever required. "
What are we looking for? "•Pharmacovigilance & Drug Safety Surveillance •Internal Audit Quality Assurance •Quality Auditing •Ability to manage multiple stakeholders •Ability to meet deadlines •Commitment to quality •Prioritization of workload •Risk management "
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 • Prepare and conduct audits, complete the checklists in the eQMS, draft audit reports, approve CAPA responses and track CAPA actions to closure. • Perform Vendor Audits. • Provide support during client audit and regulatory inspections. • Support in performing annual internal audit plan, vendor audit plan, quarterly reconciliation and perform risk assessment. • Develop procedural documents and maintain QA repository."