Quality Assurance Specialist

2 settimane fa

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

**About Evotec Modena Srl**

Evotec Modena Srl is a leading biotechnology company specializing in the discovery and development of novel small molecule drugs. With operational sites in Europe and the US, the company has built substantial expertise in drug discovery and development, as well as an industrialized platform for driving new innovative small molecule compounds into the clinic.

**Job Summary**

We are seeking a highly motivated Quality Assurance Specialist to join our Cell Therapy Manufacturing team in Modena. This role will play a key part in ensuring the company's and intercompany ATMP manufacturing activities meet the highest standards of quality and compliance.

**Key Responsibilities**

  • Manage a comprehensive documentation system for all Cell Factory operations, ensuring accuracy and completeness.
  • Collaborate with cross-functional teams to identify and mitigate risks, and implement effective change management systems.
  • Manage deviations and corrective/preventive actions, ensuring timely resolution and root cause analysis.
  • Regularly inspect all departments to assess their GMP compliance status, providing recommendations for improvement.
  • Support the development of training plans for new and existing staff, ensuring they have the necessary skills and knowledge to perform their roles effectively.
  • Qualify external suppliers, ensuring they meet the company's quality and regulatory requirements.
  • Handle complaints and concerns from customers, stakeholders, and employees, providing timely and effective resolutions.
  • Distribute production batch records, ensuring accuracy and completeness.
  • Execute the Batch Record Review, ensuring compliance with regulatory requirements.
  • Manage document control, ensuring all documents are up-to-date, accurate, and compliant with regulatory requirements.

**Requirements**

  • Knowledge of current GxP guidelines and regulations.
  • Positive attitude, with excellent communication and problem-solving skills.
  • Accurate and detail-oriented, with excellent prioritization and organization skills.
  • Commitment to meeting deadlines and delivering high-quality results.
  • Intermediate level of English proficiency (written and spoken).
  • Good knowledge of Microsoft Office applications.

**Education**

  • BS or MS degree in a scientific field (e.g., Biotechnology, Biology, Pharmacy, CTF).

**Experience**

  • Previous experience in Quality Assurance (3+ years) is mandatory.
  • Previous experience with ATMPs and sterile products is a plus.
  • Previous experience in environmental monitoring, safety methods, and mediafill activities is a plus.

**Diversity and Inclusion**

Evotec Modena Srl is committed to diversity and inclusion, and we welcome applications from all qualified candidates, including those with disabilities.

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