Quality Auditor - GCP Animal Studies

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Job Description
Are you passionate about quality in the animal health area? Do you want to work with the most prestigious names in pharma, bio, animal health and similar regulated environments? If you have an eye for detail and want to help assure quality of life, then this is the role for you!
What to expect:
You will be part of a global quality auditing team responsible for assuring quality in the supply chains of our clients in the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries. Covering your local region, you will work closely with SQA’s operations center to coordinate, prepare, execute, and deliver supplier quality audits based on client audit schedules. You will work with SQA’s world-class production team to align your expert findings to the individual structure and guidelines of each client’s managed audit program.
What you’ll do:
You will be performing quality audits at suppliers to SQA’s clients. Each client has unique program needs to which you will be oriented as part of your on-boarding for each program. You will apply your skills and experience within the parameters of each program to produce the consistent results needed for seamless integration of audit results into each client’s supplier risk management framework.
What you’ll need:
You will need to have a proven track record in performing audits in the animal health industry. Experience with China GCP, veterinary studies, pharmacovigilance, EU 2021/1281, VICH GCP, and/or ICH E6.
As an SQA Quality Auditor, you will have at least four years experience and will be deployed based upon your subject matter expertise relative to the manufacturing environment. You will possess expert knowledge relating to specific commodities and tools. Depending on the requirements of the program, (e.g., 21CFR 210/211, 21 CFR 820, ICH guidelines, 21 CFR 58, 21 CFR 11), you shall be experienced in the commodity or activity of the auditee (e.g., API, raw materials, sterilization, components, laboratories, distribution, CROs).
Strong English speaking, reading and writing skills are necessary and willingness to travel within country or regionally is desired.
Pay Range:
$2800-3200 USD for 2 day audits. Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized. Does not include: Following up for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • China

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 16, 2024
Company Overview

Current Openings: 0

As an app development company, we don't follow the traditional development agency approach of focusing on just development; we see ourselves as a strategic partner that can help businesses thrive through innovative technological solutions. We provide honest advice and help product teams focus on what matters for their business growth. Our team is our biggest asset and number one priority. We are masters of remote work and Agile workflows, with a remote-ready team spread throughout the globe. Need a partner to develop your digital product? Visit us at: www.koombea.com to learn more about us, our services, and get in touch. Would you like to join our team? Visit our careers page at koombea.com/careers and find out more about our job openings.
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