GMP Compliance Specialist

2 mesi fa

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

Evotec is at the forefront of discovering and developing innovative small molecule therapeutics, 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 aspires 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 manufacturing site. 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 operations within the Cell Factory.
  • Engage in risk assessment and analysis.
  • Participate in the change management process.
  • Manage deviations and implement corrective and preventive actions.
  • Conduct regular inspections across all departments to evaluate their GMP compliance.
  • Assist in developing training programs for both new and existing personnel.
  • Qualify external suppliers.
  • Address and resolve complaints.
  • Distribute production batch records.
  • Perform Batch Record Reviews.
  • Manage documentation effectively.

Required Skills & Qualifications

  • Familiarity with current GxP regulations.
  • A collaborative team player with a proactive problem-solving approach.
  • Detail-oriented with strong prioritization and organizational capabilities.
  • Ability to meet deadlines consistently.
  • 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, etc.).

Professional Experience

  • A minimum of 3 years of experience in Quality Assurance is essential.
  • Experience with ATMPs is advantageous.
  • Prior experience with sterile products is preferred.
  • Familiarity with environmental monitoring, safety protocols, and media fill activities is beneficial.

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

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