Quality Assurance Analyst

1 settimana fa

Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno

Evotec is at the forefront of discovering and developing innovative small molecule pharmaceuticals, with operational facilities across Europe and the United States. The company has established a robust expertise in drug discovery and development, utilizing an industrialized platform to propel new small molecule compounds into clinical settings. Furthermore, Evotec is advancing an integrated platform aimed at delivering iPSC-based therapies to patients, alongside a pioneering portfolio of off-the-shelf cell therapy projects. By leveraging its extensive skills and knowledge, the company aims to create best-in-class differentiated therapeutics and foster superior science-driven discovery and development partnerships with pharmaceutical and biotechnology firms.

We are currently seeking a dedicated GMP Quality Assurance Specialist, preferably with experience in aseptic manufacturing, for our cell therapy production facility. This role is pivotal within the Cell and Gene Therapy team, ensuring compliance with both company and intercompany ATMP manufacturing operations.

Key Responsibilities

  • Oversee a comprehensive documentation system for all Cell Factory activities
  • Engage in risk assessment processes
  • Contribute to the change management framework
  • Manage deviations and implement corrective/preventive measures
  • Conduct regular inspections across all departments to evaluate GMP compliance
  • Assist in developing suitable training programs for both new and existing personnel
  • Qualify external suppliers
  • Address and resolve complaints
  • Distribute production batch records
  • Perform Batch Record Reviews
  • Oversee document management

Required Skills & Qualifications

  • Familiarity with current GxP regulations
  • Positive attitude, team-oriented, and adept at problem-solving
  • Detail-oriented with strong prioritization and organizational skills
  • Commitment to meeting deadlines and delivering results
  • Intermediate proficiency in English (both written and spoken)
  • Proficient in Microsoft Office applications

Educational Background

  • Bachelor's or Master's degree in a scientific discipline (e.g., Biotechnology, Biology, Pharmacy, CTF...)

Professional Experience

  • Minimum of 3 years of experience in Quality Assurance is essential
  • Experience with ATMPs is advantageous
  • Familiarity with sterile products is preferred
  • Background in environmental monitoring, safety protocols, and media fill operations is beneficial

In line with our Diversity policy, Evotec welcomes applications from all qualified candidates, including individuals with disabilities.

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