Healthcare Quality Assurance Auditor

1 month ago

Gujrat, Punjab, Pakistan Eurofins GSC Poland Sp. z o. o. Full time

Lead Auditor- Healthcare

 

About the Role:

We are seeking a highly skilled Lead Auditor to join our team in Quality Assurance department. The ideal candidate will have a strong background in pharmaceuticals, medical devices, or cosmetics and possess excellent audit skills.

Key Responsibilities:

The successful candidate will be responsible for conducting audits at suppliers in accordance with reference regulations, Eurofins Sisthema procedures, and specific customer requests. This will include drafting audit reports within agreed timelines.

Macro Areas of Activity:

  • Pre-audit
    • Management of Pre-Audit Documents
    • Preparation of Audit Agenda
    • Collaboration in Travel Preparation
  • Audit
    • Conducting the Audit
  • Post-audit
    • Drafting of Audit Reports and Audit Comments
    • Evaluation of CAPA Plan

Cross-Functional (Internal and External) Relations:

The successful candidate will interact with various stakeholders, including customers, suppliers, QA, Finance, and other departments.

Requirements:

To be successful in this role, you will need:

  • Educational Qualification:
    • Scientific Degree (preferably Pharmacy, Chemistry, and Pharmaceutical Technology, Chemistry)
    • Technical Audit Report Writing Skills
  • Previous Experience:
    • Minimum 10 years of experience in pharmaceuticals, medical devices, and/or cosmetics (QA, Regulatory Affairs, QC, Consulting)
    • Conducting at least 10 supplier audits and/or internal audits
  • Knowledge of:
    • EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716, CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office
  • Specific Technical Practical Skills (Know-how):
    • Conducting Audits of Quality Management Systems
  • Transversal Skills:
    • Attention to Order and Quality Self-control
    • Autonomy Analytical Capacity
    • Customer and Result Orientation Confidentiality Compliance with Planned Timelines

Salary: €80,000 - €100,000 per annum

Benefits:

We offer a competitive salary, use of equipment, utilities, software (Microsoft Office, LIMS, SAP, CDS system), certifications (Quality Management System, Computer System Validation, Six Sigma, ISO), and opportunities for professional growth and development.