Quality Auditor - Biologics

Are you passionate about quality in the life sciences 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!

This is a local role.

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 life sciences. 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. Depending on your capability, capacity, and availability, you could perform between 5-20 audits per year.

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 of APIs, Excipients, Packaging or related manufacturing processes and be thoroughly familiar with GMP regulations for the life sciences industry.

As a Senior Quality Auditor, you will have at least five 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, you may be trained and certified by a recognized industry body to perform quality audits in a specific environment to be audited (e.g., 21CFR 210/211, 21 CFR 820, ICH guidelines, 21 CFR 58, 21 CFR 11), and 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 traveling within country or regionally is desired.

Required Experience: Drug/Biologics GMP's, ISO 9001, ISO 14001, and ISO 13485