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Quality Auditor - Pharmaceutical/Medical Device

SQA Services -
Köln

Direkt bewerben

Details zur Stelle

1.700 € pro Tag

Leistungen

Reisekostenerstattung

Qualifikationen

Schreibfähigkeiten
Qualitätssicherung
Software-Qualitätssicherung

Vollständige Stellenbeschreibung

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 Germany and its bordering countries. 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, ISO 13485, and 21 CFR 820
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, and animal health
ISO certifications are a plus but not mandatory

Pay Rate:

$1700 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.

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.

#ZR

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Direkt bewerben

Erweiterte Suche

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Quality Auditor - Pharmaceutical/Medical Device

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Ich möchte aktuelle Job-E-Mails für Stellen als content network in langenfeld erhalten

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