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- Tasks: Conduct audits to ensure compliance with regulations and guidelines in the pharmaceutical industry.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Competitive salary, travel opportunities, and professional development in a dynamic environment.
- Why this job: Make a real impact on patient outcomes while working with innovative medical treatments.
- Qualifications: 10 years in pharma with 5 years in Quality Assurance; GCP audit experience required.
- Other info: Opportunity for career growth and collaboration with a talented team.
The predicted salary is between 48000 - 72000 £ per year.
Plan 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 customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
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, IQVIA 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 and formulation of corrective action plans.
- Manage Quality Issues.
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
- 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.
- Host audits/inspections.
- Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
- May perform GLP Archivist duties where needed.
- Manage/oversee quality events updates in eQMS and/or maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements.
- Assist in training of new Quality Assurance staff.
Qualifications
- Ability to travel 15-20% across Europe.
- 10 years experience in pharmaceutical, technical, or related area, of which 5 years in Quality Assurance. GCP audit experience is a must.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Excellent problem solving, risk analysis and negotiation skills.
- Strong training capabilities.
- 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.
This role is not eligible for UK Visa sponsorship.
Sr. QA Auditor, GCP in Livingston employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. QA Auditor, GCP in Livingston
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to shine during those interviews, so practice common questions and have your own ready to show your interest!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. We recommend mentioning something specific from your conversation to show you were engaged and are genuinely interested in the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we often have exclusive roles listed there that you won’t find anywhere else!
We think you need these skills to ace Sr. QA Auditor, GCP in Livingston
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sr. QA Auditor role. Highlight your GCP audit experience and any relevant qualifications that match the job description. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role. Mention specific experiences that demonstrate your knowledge of compliance and quality assurance processes. Let us know why you’re excited about joining StudySmarter!
Showcase Your Problem-Solving Skills: In your application, don’t forget to highlight your problem-solving and risk analysis skills. Give examples of how you've tackled challenges in previous roles, especially in relation to audits or compliance. We love seeing candidates who can think on their feet!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining the StudySmarter team!
How to prepare for a job interview at IQVIA
✨Know Your Regulations
Make sure you brush up on the key regulations and guidelines relevant to GCP audits. Familiarise yourself with the latest updates in the pharmaceutical industry, as this will show your commitment and expertise during the interview.
✨Prepare for Scenario Questions
Expect to be asked about specific audit scenarios or compliance challenges. Think of examples from your past experience where you successfully navigated these situations, and be ready to discuss your thought process and outcomes.
✨Showcase Your Communication Skills
As a Sr. QA Auditor, you'll need to communicate findings effectively. Practice articulating complex information clearly and concisely. You might even want to prepare a mock presentation of an audit report to demonstrate your skills.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to compliance and quality assurance initiatives. This not only shows your interest but also helps you gauge if the company aligns with your values.
