Senior Pv Qa Auditor

4 weeks ago

Bangalore Karnataka, India IQVIA Full time

Job Overview Plan schedule and conduct independent audits to assess compliance with regulations guidelines and operating procedures Prepare and distribute reports of findings to supervisor operations staff management and clients Review approve and follow-up on corrective and preventive action CAPA plans on audit findings to closure Provide consultation in interpretation of regulations guidelines policies and procedures and support management in the promotion and assessment of compliance to regulations guidelines and corporate policies Essential Functions Plan schedule and conduct independent audits of IQVIA s post-marketing pharmacovigilance and or Real World Solutions activities and services to assess compliance with regulations guidelines and operating procedures Evaluate audit findings and prepare and distribute reports to operations staff management and clients Review and approve Root Cause Analysis RCA Corrective Action and Preventive Action CAPA plans and Effectiveness Checks EC plans for audit findings Track and follow up on the CAPA and EC implementation to closure Maintain records in the electronic Quality Management System eQMS in relation to the audit lifecycle Provide interpretation of and consultation on regulations guidelines compliance status policies and procedures to IQVIA staff Evaluate policies and procedures for compliance with applicable regulations guidelines and provide recommendations to management for continuous process improvements Mentor support and assist in the training of new or less experienced auditors Support management in the development of the risk-based tactical and strategic audit plans Assist in the provision of Quality Assurance data for Clients Pharmacovigilance System Master Files PSMF Assist in the development and reporting of quality metrics for IQVIA s Quality Management System May provide Quality Assurance consultancy to IQVIA project teams and their Clients within budget and established timelines May lead collaborate or support QA improvement initiatives Qualifications Essential Bachelor s degree in a scientific or healthcare related field or equivalent Five years post-marketing pharmacovigilance GVP experience in a Pharma or CRO environment Three to five years experience in the planning conducting and reporting of audits Proven knowledge of quality assurance principles and processes Extensive knowledge of pharmaceutical research and development processes and regulatory environments Strong interpersonal skills and the ability to positively influence and guide others Excellent problem solving risk analysis and negotiation skills Effective organization communication and team orientation skills Ability to initiate assigned tasks and to work independently Demonstrated ability to manage multiple responsibilities Desirable Experience of GCP requirements and GCP auditing Knowledge and understanding of Medical Devices Auditing qualification e g ISO 9001 Lead Auditor IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at

  • QA Auditor

    1 week ago

    Bengaluru, Karnataka, India Navitas Life Sciences Full time

    Job Description We are currently seeking a QA Auditor - PV to join our growing team. The role will include the following: - Implement and maintain the pharmacovigilance system, quality process and metrics - Conduct audits of projects, systems, processes, and vendors, as assigned - Support with preparation for hosting customer audit and PV inspections -...

  • Senior QA Auditor/ Senior GCP Auditor

    2 weeks ago

    bangalore, India Tilda Research Full time

    Remote: IndiaOpen to candidates with experience in global clinical research operations.About the RoleWe are seeking a Senior QA Auditor/ Senior GCP Auditor professional with proven experience in audits, SOP management, and regulatory compliance across global clinical research environments. This role is ideal for someone who has worked within or closely with...

  • Qa Auditor- Clinical

    3 weeks ago

    Bangalore, Karnataka, India Syngene International Full time

    Job Title QA Auditor- Clinical Job Location Bangalore About Syngene Syngene www syngeneintl com is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has...

  • Senior Auditor

    1 week ago

    Bangalore, Karnataka, India Lowe's Full time

    About Lowe s Lowe s is a FORTUNE 100 home improvement company serving approximately 16 million customer transactions a week in the United States With total fiscal year 2024 sales of more than 83 billion Lowe s operates over 1 700 home improvement stores and employs approximately 300 000 associates Based in Mooresville N C Lowe s supports the communities it...

  • Qa Auditor- Gcp Compliance

    3 weeks ago

    Bangalore, Karnataka, India Syngene International Full time

    JOB DESCRIPTION Job Title Associate Manager Compliance QA Auditor Job Location Bangalore Job level 7-I About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and...

  • High Salary! Qa Auditor- Cdm

    3 weeks ago

    Bangalore, Karnataka, India Syngene International Full time

    JOB DESCRIPTION Job Title Clinical Data Management QA Auditor Job Location Semicon Park About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally...

  • [Apply Now] Qa Auditor- Ctm

    3 weeks ago

    Bangalore, Karnataka, India Syngene International Full time

    JOB DESCRIPTION Job Title Clinical Trial Management - QA Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene...

  • High Salary! Compliance Qa Auditor

    2 weeks ago

    Bangalore, Karnataka, India Syngene International Full time

    Job Title Assistant Manager -Compliance QA Auditor Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has...

  • Pv Data Assurance Professional

    1 week ago

    Bengaluru, Karnataka, India Astellas Full time

    Purpose and Scope: Responsible for development and maintenance of excellence in Data Assurance, with a focus on operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the Astellas PV Case Management functions, regions and case processing...

  • Senior Internal Auditor

    2 weeks ago

    bangalore, India Regenta Central Antarim Full time

    Company DescriptionThis position is responsible for the following hotel. Regenta Central Antarim - AhmedabadKeys Select by Lemon tree - AhmedabadGrand Mercure Candolim - GoaRegenta Central Mewargarh - UdaipurFern Bambora Fort - UdiapurLemon Tree Resort - SomnathRole DescriptionThis is a full-time, on-site role for a Auditor located in Ahmedabad. Travelling 5...