Quality Auditor - Pharmaceuticals
Tokyo / Kanagawa / Nigata / Fukuoka / Kawasaki / Nagoya / Kyoto / Kobe / Osaka / Saitama / Sapporo / Yokohama / Hiroshima
Life Sciences – Pharmaceutical /
Audit - Multiple Events /
On-site
For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
We’re hiring a Pharmaceutical Auditor. This is a contract opportunity in which you will perform 1-2 day audits at various suppliers in Japan. You are given the flexibility to accept or reject these assignments according to your own availability.
Key Responsibilities
- Perform supplier audits at various sites within Japan
- Assure quality in the supply chains of various clients within the animal health, pharmaceutical, medical device, cosmetics, 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 animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Direct audit experience to 21 CFR part 210/211, EU GMP, EU Vol 4, ISO 9001, and ICH Q7
- Strong communication and writing skills
- Proven ability to deescalate workplace conflicts effectively
- Ability to adapt to new technology and software
- Willingness to travel
Preferred Qualifications
- Strong experience with 21 CFR part 58, 21 CFR part 820, EU GDP, ISO 15378, ISO 17025
- ISO certifications are a plus but not mandatory
$1,600 - $1,700 a day
$1600-$1700 for a 1-day audit. 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 on CAPA 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.
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.
