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Regulatory Project Director

Il y a 2 mois


Orléans, Centre-Val de Loire, France PQE Group Temps plein
About PQE Group

PQE Group is a world leader in the Pharmaceutical and Medical Device industries, with a strong presence in Europe, Asia, and the Americas. With over 40 subsidiaries and more than 2000 employees, we have been at the forefront of these industries since 1998.

Job Description

We are seeking a highly skilled Compliance Qualification & Validation Project Manager to support our projects in the Pharmaceutical industry. As a key member of our team, you will be responsible for:

Key Responsibilities
  • Developing processes and procedures for the Qualification/Validation department to meet regulatory requirements and industry standards.
  • Reviewing and improving Qualification/Validation processes to ensure compliance and efficiency.
  • Creating or modifying documentation, including procedures and operating modes, to meet industry standards.
Requirements
  • 5+ years of experience in Qualification/Validation in a Pharmaceutical context.
  • Strong understanding of Quality Assurance principles and regulatory requirements in the Pharmaceutical industry.
  • Mastery of pharmaceutical standards and regulations.
  • Excellent communication and influencing skills to mobilize stakeholders and ensure project success.
  • A necessary level of English proficiency to draft Qualification/Validation documents in French and English.
  • Experience in Validation for experimental drugs is a plus.
About You

We are looking for a highly motivated and experienced professional who is passionate about Quality Assurance and regulatory compliance. If you have a strong background in Qualification/Validation and a desire to work on international projects, we encourage you to apply.