Quality Auditor - Pharma/Cell Therapy

View The Space; À distance; EUR 40 000 - 60 000; Temps partiel

Résumé du poste

A leading quality assurance firm is hiring for a GMP auditing role in France, specifically in Vannes. Candidates will perform 1-2 day audits at suppliers in the pharmaceutical and medical device sectors. A minimum of 5 years of hands-on audit experience is required, along with strong communication skills and the ability to de-escalate conflicts. The role requires regional travel and involves report writing and interaction with clients. Compensation is $1,600 per day for audits.

Qualifications

• 5+ years of hands-on audit experience in the pharmaceutical sector.
• Direct audit experience to GMP is essential.
• Proven ability to adapt to new technology.

Responsabilités

• Perform supplier audits at various sites.
• Assure quality in supply chains for pharmaceuticals.
• Write audit reports per client specifications.

Connaissances

Audit experience

Communication skills

Regulatory knowledge

Conflict de-escalation

Description du poste

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 GMP opportunity in which you will perform 1-2 day audits at various suppliers in France. 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
• Direct audit experience to 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

• Strong experience with 21 CFR part 1271 and cellular therapy
• ISO certifications are a plus but not mandatory

$1,600 - $1,600 a day

$1400 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.

Note: 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.