Quality Auditor - Pharmaceutical at SQA Services

Company OverviewFor 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.Job DescriptionWe’re hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in the United Kingdom. These audits are 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.Key ResponsibilitiesPerform supplier audits at various sites within your region of residenceAssure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industriesCoordinate, prepare, execute, and deliver supplier audits based on your own and the client scheduleUtilize 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 reportWrite audit reports in accordance with client specificationsRequired Qualifications5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industriesHas been the lead auditor in at least 10 auditsDirect audit experience to 21 CFR part 210/211, ANVISA RDC 301, Canada GUI-0001, China Food and Drug Administration/National Mediccal Products Administration, Japan MHLW Ordinance No. 136, and EU Vol 3Strong communication and writing skillsProven ability to deescalate workplace conflicts effectivelyAbility to adapt to new technology and software.Willingness to travel regionallyPreferred QualificationsDirect audit experience to 21 CFR part 210/211, and Advanced Therapy Medicinal Products for Human UseISO certifications are a plus but not mandatoryPay Rate$1800 USD 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.

Quality Auditor - Pharmaceutical

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

About SQA Services:

www.sqaservices.com/

Admin access needed