Quality Auditor - Pharma/Cell Therapy at SQA Services – Chartres-de-Bretagne, Bretagne

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.
Were looking for Pharma GMP and/or Cell Therapy Quality Auditors. This is a contract opportunity in which you will perform 1-2 day audits at various suppliers in France. We are ideally looking for someone who has availability to do 3-4 audits a month. 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
• Served as a lead auditor in at least 5 audits
• 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

$1600 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.
$1,600 - $1,600 a day