Freelance Auditor
About Qualifyze:
Founded in 2019, Qualifyze is a leading company in supply chain compliance management in the Life Sciences industry, trusted by over 1,500 pharmaceutical and healthcare companies globally. Our digital suite of solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts. With a track record of over 4,500 GxP audits across 85+ countries and the largest and most accurate supplier network and data analytics tools, Qualifyze stands as the all-in-one partner for quality compliance and supply chain risk mitigation in the Life Sciences sector.
We provide flexible collaboration opportunities for qualified auditors worldwide. Many of our auditors are freelancers or combine auditing with their current roles, working with us on demand based on their expertise, availability, and location.
Role Overview:
We are looking for a Freelance Quality Auditor to join our team and support quality audits on demand. This is a freelance opportunity for an experienced professional who is passionate about quality standards in the Health & Life Sciences industry and is ready to make an immediate impact.
Main responsibilities:
Work closely with our Quality Officers, who provide audit preparation materials and agenda support and preparing the audit using the shared information
Conduct audits at supplier sites, taking into account customer-specific requirements and agreed audit agendas
Deliver high-quality, accurate audit reports within established timelines
Collaborate with the Qualifyze team on report revision and CAPA review to ensure thorough and objective audit findings
Main requirements:
Educational background in Health & Life Sciences, or demonstrated long-term experience in the industry (minimum 10 years in Pharma or an applicable Health & Life Sciences sector)
Strong, hands-on experience within the applicable Health & Life Sciences industry
Proven track record of conducting audits, with consistent and verifiable records of audit activity within the last 3 years
Evidence of relevant and accredited auditor training, or demonstrated experience conducting initial audits under the guidance of experienced auditors
Good level of English, both written and spoken
Agreement & Compensation:
Upon successful completion of the qualification process, a collaboration agreement will be established outlining the terms of our working relationship.
Compensation includes a standard audit fee applicable across all audit types. For multi-day audits, additional compensation will be agreed upon on a case-by-case basis. All reasonable travel expenses incurred during audit assignments are fully reimbursed.
Following the review of your profile at the initial stage of the qualification process, we will reach out to transparently share the compensation range we are offering - which will be specific to your experience and location - ensuring an open and straightforward conversation from the start.
Use of AI in Our Recruitment Process:
We believe in a human-led hiring process. All applications are reviewed manually by our Talent Acquisition team, and neither Talent Acquisition nor Hiring Managers use AI to screen, filter, rank, assess, or make decisions about candidates, including during interviews and assessments. During interviews, AI may be used only to support note-taking and transcription.
All hiring decisions are made by people!
Diversity & Inclusion at Qualifyze:
At Qualifyze we actively support the power of diversity, uniting complementary talents and perspectives to address new challenges. Our collective strengths help us to find innovative solutions and turn difficulties into opportunities. We will encourage you to bring your authentic self to work, fostering an inclusive environment where everyone belongs and feels heard.
We are an equal opportunity employer and we welcome applications from candidates of all backgrounds, regardless of race, ethnicity, gender identity, sexual orientation, marital status, religion, disability, or age. Our hiring practices are rooted in fairness and respect, and we strive to create a culture where everyone feels valued and empowered.
As published by recruitee · 37 questions · 2 written answers
Basics
Full name, Email, CV, Phone
Short answers (23)
- What is your current country of residence?
- Date of birth
- How many audits have you conducted throughout your career in total?
- How many Starting Materials for API production audits have you conducted and what criteria or standards were applied? (e.g. APIC Guide for auditing registered starting material manufacturers) optional
- How many Non-sterile API (Drug substance) audits have you conducted and what criteria or standards were applied? (e.g. ICH Q7 / EU GMP Part II) optional
- How many Sterile API (Drug substance) audits have you conducted and what criteria or standards were applied? (e.g. ICH Q7 / EU GMP Part II) optional
- How many Excipients audits have you conducted and what criteria or standards were applied? (e.g. IPEC–PQG GMP Guide for pharmaceutical excipients) optional
- How many Non-sterile FDF (Drug product) audits have you conducted and what criteria or standards were applied? (e.g. EU GMP Part I + Annexes) optional
- How many Sterile FDF (Drug product) audits have you conducted and what criteria or standards were applied? (e.g. EU GMP Part I + Annexes) optional
- How many Distribution and/or transportation audits have you conducted and what criteria or standards were applied? (e.g. EC GDP Guidelines 2015/C 95/01 or 2013/C 343/01) optional
- How many Subcontracted laboratories for GMP testing audits have you conducted and what criteria or standards were applied? (e.g. EU GMP Part I / Part II / ICH Q7) optional
- How many Subcontracted laboratories for GLP testing audits have you conducted and what criteria or standards were applied? (e.g. Good Laboratory Practice principles) optional
- How many Testing and calibration laboratory audits have you conducted? (e.g. ISO 17025) — Approximate number is fine optional
- How many Packaging components manufacturer audits have you conducted and what criteria or standards were applied? (e.g. ISO 15378:2017 for primary / ISO 9001:2015 for secondary) optional
- How many QMS audits have you conducted and what criteria or standards were applied? (e.g. ISO 9001:2015) optional
- How many Medical Devices audits have you conducted and what criteria or standards were applied? (e.g. EU MDR 2017/745 / ISO 13485:2016) optional
- How many Pharmacovigilance audits have you conducted and what criteria or standards were applied? (e.g. Guideline on Good Pharmacovigilance Practices – GVP) optional
- How many GCP audits have you conducted and what criteria or standards were applied? (e.g. ICH E6 (R3) — CROs, Investigator Sites, Sponsors) optional
- How many Software provider audits for the pharma industry have you conducted and what criteria or standards were applied? (e.g. GAMP 5 – second edition) optional
- How many Food Safety audits have you conducted and what criteria or standards were applied? (e.g. ISO 22000:2018) optional
- How many Cosmetics audits have you conducted and what criteria or standards were applied? (e.g. ISO 22716:2007) optional
- How many GACP (Good Agricultural and Collection Practice) audits have you conducted and what criteria or standards were applied? optional
- If you selected "Other", please specify your specialised audit experience. optional
Pick from a list (10)
- Are you comfortable working in English?
- What is your current working status? (e.g. employed, self-employed, freelance, unemployed)
- Do you have any specialised audit experience? Select all that apply. optional
- Are you able to write reports, and communicate professionally in English? optional
- Do you consistently demonstrate ethical, independent, and responsible conduct during all phases of an audit (including situations that may involve disagreement or confrontation)?
- Are you open to different types of evidence and viewpoints when forming audit conclusions, and do you actively seek to improve your audit practice?
- Are you conscious of and respectful toward the auditee's workplace culture and rules, and do you collaborate effectively to facilitate productive interactions?
- Do you actively observe auditee conditions and have the ability to understand people, processes, and culture across different situations?
- Can you adapt to different situations while remaining focused and applying a logical, systematic approach to planning, conducting, and reporting audits?
- I confirm I have read and agree to Qualifyze's Data Privacy for Job applicants (please click on the link in the info box below). Please note that we will not be able to proceed with your application should you not read and accept our Data Privacy policy.
Written answers (2)
- How many audits have you conducted in the last 3 years?
- In which languages are you able to conduct an audit, and at what level? (e.g. Spanish – Native, English – C1) optional
Attachments (2)
- Please upload your relevant certificates and qualifications, including your university degree, below. optional
- Do you hold professional liability insurance? If yes, please upload proof of coverage below. optional