Quality Auditor PharmaceuticalMedical Device
Job Summary
- 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
- 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 ISO 9001
- Strong communication and writing skills
- Proven ability to deescalate workplace conflicts effectively
- Ability to adapt to new technology and software.
- Willingness to travel regionally
- Direct audit experience to ISO 17025 ISO 15378 IPEC GDP ICH Q7 and/or ISO 13485
- ISO certifications are a plus but not mandatory
Required Experience:
IC
About Company
SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status. ... View more