Quality Auditor - Pharmaceutical
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About the role
Key Responsibilities
Perform supplier audits at various sites within your region of residence
Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc…
Respond to the Content team in a timely manner regarding edits/questions to your audit report
Write audit reports in accordance with client specifications
Required Qualifications
5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
Has been the lead auditor in at least 10 audits
Direct audit experience to 21 CFR part 210/211, EU Vol 4, and Canada GMP
Strong communication and writing skills
Proven ability to deescalate workplace conflicts effectively
Ability to adapt to new technology and software.
Willingness to travel regionally
Preferred Qualifications
Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 CFR 507
ISO certifications are a plus but not mandatory
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