QA Auditor Ii

3 days ago

Bengaluru, India IQVIA Full time

Job Overview

Conduct and/or support audits and report preparation/distribution, Support quality issues management, Customer Audit/ Regulatory Inspections hosting, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements

Essential Functions
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures ( SOPs) and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers and monitors in interpretation of audit observations
- Host audits/inspections, Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections. - Manage Quality Issues
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Assist in training of new Quality Assurance staff.
- Support in QA initiatives/projects for quality, process improvements
- Manage/oversee quality events updates in eQMS
- Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle

**Qualifications**:

- Bachelor's Degree preferred
- 3-7 years’ experience working within a regulated environment with basic familiarity with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc.
- 2 years’ experience in Quality Assurance role in a regulated environment or ISO 9000 certified company required
- Experience in hosting and/or conducting audits of computerized systems with clinical trial relevance. Familiarity with computerized systems validation methodologies.
- 3 years’ experience in Clinical, pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience preferred
- Considerable knowledge of GXP regulations and quality assurance auditing techniques..
- Strong communication and interpersonal skills. Excellent problem solving skills.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

  • QA Auditor

    5 days ago

    Bengaluru, Karnataka, India Labcorp Full time

    The job will involve: Conducting regulated study protocol reviews, data and report audits for Toxicology and supporting Dose Analysis Analytical chemistry audits - Follow applicable approved policies and SOPs - Navigate to the regulations and able read/understand specific regulations - Perform review of protocols/amendments and report audits. - Timely notify...

  • QA Analyst II

    1 week ago

    Bengaluru, Karnataka, India CME Group Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    The QA Analyst II is an intermediate test engineer who is technically strong and has the business knowledge to execute, analyze, deliver and support any feature in the application. The incumbent must establish and maintain testing environments as well as analyze, verify, and troubleshoot test results against requirements. The QA Analyst II is required to...

  • QA Analyst II

    7 days ago

    Bengaluru, India CME Group Full time

    Job Description The QA Analyst II is an intermediate test engineer who is technically strong and has the business knowledge to execute, analyze, deliver and support any feature in the application. The incumbent must establish and maintain testing environments as well as analyze, verify, and troubleshoot test results against requirements. The QA Analyst II is...

  • Senior qa auditor/ senior gcp auditor

    10 hours ago

    Bengaluru, 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...

  • Compliance QA Auditor

    1 week ago

    Bengaluru, Karnataka, India Syngene Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Title: Assistant Manager -Compliance QA AuditorJob Location: BangaloreAbout 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....

  • Auditor - Mhs

    3 days ago

    Bengaluru, India TÜV SÜD Full time

    **Tasks** - **I.** **Responsibility and Authority** - 1. Perform audit according to standard requirements, regulatory requirements, internal requirements, code of conduct. - 2. Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities. - 3. Review medical...

  • QA Auditor Ii

    1 week ago

    Bengaluru, India Labcorp Full time

    **Essential Job Duties**: - Follow applicable policies and SOPs - Navigate to the regulations and able read/understand specific regulations - Perform review of protocols/amendments and report audits - Timely notification to management regarding identification of critical issues - Successful relationships on one-to-one basis. Able to answer questions...

  • QA Engineer

    4 weeks ago

    Bengaluru, India LightFury Games Full time

    Job Description Job Title: QA Engineer - II Location: Bangalore, India Company: Lightfury Games About LightFury LightFury is poised to become India's premier AAA game development company. We're driven by a passion for gaming and innovation, aiming to set new benchmarks in the industry. We value diversity and are committed to creating an inclusive environment...

  • QA Auditor

    6 days ago

    Bengaluru, India IQVIA Full time

    Job Overview Conduct and/or support audits and report preparation/distribution, Support quality issues management, Customer Audit/ Regulatory Inspections hosting, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development. Provide consultation in interpretation of regulations,...

  • Software Engineer II- QA

    1 day ago

    Bengaluru, India JPMorgan Chase & Co. Full time

    We have an exciting and rewarding opportunity for you to take your software engineering career to the next level.  As a Software Engineer II at JPMorgan Chase within the Consumer and Community Banking - Wealth Management, you will be a seasoned member of an agile team, tasked with designing and delivering trusted, market-leading technology products in a...