layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Quality Auditor - Pharmaceutical/Medical Device
SQA Services
Tokyo
Source: SQA Services careers · View original posting
Employer job description
From SQA Services's posting. “We” and “our” refer to the employer.
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 Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in Japan. These audits are generally 1-2 days long. 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 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 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
- Preferred Qualifications: Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or ISO 13485
- ISO certifications are a plus but not mandatory
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