Quality Compliance Specialist

4 settimane fa


Montà, Italia Tevapharm A tempo pieno

We are seeking a brilliant Quality Compliance Specialist to join our team. This role involves performing risk assessments, preparing sites for authority inspections, and executing internal audits to ensure compliance with cGMP standards.

The ideal candidate will have a strong background in quality assurance, preferably with experience in drafting risk assessments and managing audits. They will also be skilled in data integrity application and have a good command of English.

As a Quality Compliance Specialist, you will work closely with our compliance team to ensure that our site meets the highest standards of quality. You will be responsible for performing investigations, drafting and maintaining site master files, and providing GMP training to site personnel.

In return, we offer a highly inclusive and multicultural working environment, continuous learning and development programs, and a flexible working environment. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

Main Responsibilities:

  • Perform risk assessments and gap assessments using various tools
  • Prepare sites for authority inspections and execute regulatory inspections
  • Execute internal audits and quality walk-arounds to ensure site compliance with cGMP standards
  • Manage supplier relationships and ensure compliance with internal procedures
  • Draft and maintain site master files and perform GMP training for site personnel

Requirements:

  • Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a closely related discipline
  • At least 3 years of work experience in quality assurance, preferably with experience in risk assessment and audit management
  • Strong experience in data integrity application and good command of English

We offer:

  • A highly inclusive and multicultural working environment
  • Continuous learning and development programs
  • A flexible working environment


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