Quality Auditor (Eastern Europe)
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 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.
As a Quality Auditor, you will play a key role in ensuring pharmaceutical suppliers meet the highest standards of quality and regulatory compliance. Working within the Quality team, you will independently manage and conduct audits across an international supplier network, collaborating closely with customers, suppliers, and internal stakeholders to drive quality and continuous improvement.
Main Responsibilities:
Prepare GxP audits, ensuring customer requirements and applicable regulations are adequately addressed.
Conduct 40 remote and on-site audits of pharmaceutical providers per year.
Assess compliance against applicable GxP regulations, guidelines, and internal procedures.
Prepare clear, accurate, and timely audit reports in accordance with internal quality standards.
Participate in the audit report review process, collaborating with cross-functional teams to ensure consistency and quality.
Review and assess supplier CAPA responses to ensure audit findings are appropriately addressed.
Communicate effectively with suppliers, customers, and internal stakeholders throughout the audit lifecycle.
Maintain up-to-date knowledge of applicable GxP regulations and industry best practices.
Support continuous improvement initiatives related to auditing methodologies, procedures, and quality processes.
Job Requirements:
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotech, Life Sciences, or related field.
Minimum 5 years of GMP auditing experience in the pharmaceutical industry.
Evidence of relevant and accredited auditor training or justified experience in auditing with experienced inspectors.
Strong knowledge of international GMP regulations and quality systems.
Excellent organizational, communication, and report-writing skills.
Professional proficiency in English and one of the following languages: Polish, Czech, German, Hungarian, Romanian, Bulgarian, Slovakian, or Serbian. Any additional languages would be a plus.
Willingness to travel for on-site audits (domestic and international).
💰 Salary:
At Qualifyze, our salary ranges are transparent internally, and we aim to follow a similar approach externally. For this role, we’re happy to share a reference point within the band: the expected salary range is around €25.000 – €40.000 centred around the median.
Final compensation will depend on experience and performance during the process, with some flexibility within the range. Your exact employment terms will be in line with the local laws and regulations of your country of employment.
What do we offer?
💰Competitive, annually reviewed compensation package.
🌴Country vacation package that increases with your tenure.
⏳ Flexible schedules throughout the year.
🌍 The option to work from abroad for up to 45 days per year.
💻 All necessary work equipment (laptop, headphones, etc.).
🎉 Two official company events per year to celebrate success.
🚀 Individual coaching and mentoring on your development roadmap within Qualifyze.
👫Working with an exceptional team, doing some of the best work of your career.
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, Cover letter, Phone
Short answers (22)
- What is your current country of residence?
- 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 (12)
- What country are you applying for?
- Do you have work permit for the country you are applying for?
- If you are not currently based in any of the mentioned countries, are you willing to relocate to one of these countries for this role?
- Are you comfortable working in English?
- 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 (1)
- Please upload your relevant certificates and qualifications, including your university degree, below. optional