Quality Assurance Specialist

Skill required: Quality Governance & Operations - Operational Audit & Compliance
Designation: Quality Assurance Specialist
Qualifications:BSc/MSc/Bachelor of Pharmacy
Years of Experience:7 to 11 years
Language - Ability:English - Proficient
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? 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 Quality Governance team which is responsible for Review compliance to project specific requirements for maintaining the compliance to Policies, procedures, regulations.. Perform process risk assessments of the assigned projects. Identify actions and track them to closure, Perform process level checks using approved checklists and submit all reports on time., Conduct relevant trainings for new hires / any revised courses / awareness trainings as applicable. Provide guidance and review all deviations/CAPA, provide support in RCA and submit relevant documents and evidences to QA team. • Provide support to Operations team to achieve 100% compliance to tasks as per client requirement, Engage in CSV compliance activities at Engagement and Pharma level, as applicable.
What are we looking for? •Quality Management •Clinical Data Management •Quality Assurance (QA) • Bachelor’s degree in life sciences or knowledge equivalent to that attained with a bachelor’s degree, preferred. • Minimum 5 years of experience in pharma industry for respective levels. • Knowledge and general understanding of ICH, GCP, and regulatory requirements. • Must have a basic understanding of the conduct of clinical trials, clinical trial-related systems and procedures, the nature of the drugs being studied, and applicable regulations. Aptitude to learn basic document review and audit techniques procedures. • Must have good verbal and written communication skills and good people skills (Customer oriented). • Shows strong initiative and desire to learn. Ability to exercise sound judgment. Readily adapts to changing work priorities. • Working experience in MS Office and emails •Client Data Protection (CDP) Compliance
Roles and Responsibilities: • Review compliance to project specific requirements for maintaining records/documents, viz., hard copy and/or soft copy of onboarding, off boarding, training records, Organogram, Members List, Project access control records, JD, CV, HOTO forms, list of essential documents, minutes of meetings, governance decks, audit CAPA and its evidences, Pharma IT Controls list, GDPR compliance of all tools, list of SOP/SWI, controlled copies of project specific SWIs etc. • Perform process risk assessments of the assigned projects. Identify actions and track them to closure. • Perform process level checks using approved checklists and submit all reports on time. • Conduct relevant trainings for new hires / any revised courses / awareness trainings as applicable • Provide monthly inputs for inspection readiness in IR tool. Track and update status of IR action items. • Provide support during audits/ Inspections and manage the logistics for client and internal audits. • Provide guidance and review all deviations/CAPA, provide support in RCA and submit relevant documents and evidences to QA team. • Ensure all applicable CDP controls are updated and monitored on an ongoing basis. As applicable, perform monthly CDP floor walk including Pharma IT control check and update the results in CDP portal. • Provide support to Operations team to achieve 100% compliance to tasks as per client requirement. • Engage in CSV compliance activities at Engagement and Pharma level, as applicable • Responsible for people management, provide timely feedback and help team improve performance, as applicable. • Perform any other activities as specified by the Leadership Team