Quality Assurance Specialist Modena

Quality Assurance Specialist
Modena
Emilia Romagna, Modena

Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US.

The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic.

In addition, Evotec is building an integrated platform to deliver iPSC-based therapeutics to patients and an innovative off-the-shelf cell therapy project portfolio.

Leveraging these skills and expertise the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery and development alliances with pharmaceutical and biotechnology companies.

For our cell therapy manufacturing site in Modena, we are looking for a highly motivated GMP Quality Assurance, possibly experienced in aseptic manufacturing.

This position will have a key role in Cell and Gene therapy team to guarantee company and intercompany ATMP manufacturing activities.

Essential Functions

- manage a comprehensive documentation system for all Cell Factory operations

- collaborating in risk analysis

- collaborating in change management system

- managing deviations and corrective/preventive actions

- regularly inspect all departments and assess their GMP compliance status

- support the development of appropriate training plans for new and existing staff

- qualify external suppliers

- handling complaints

- distributing production batch records

- execute the Batch Record Review

- Document management

Required Skills & Abilities

- Knowledge of current GxP guidelines

- Positive, team player and problem-solving attitude

- Accurate, with excellent prioritization and organization skills

- Commitment to the assigned deadlines and ability to deliver them tightly

- English intermediate level is required (written and spoken)

Education

- BS or MS Scientific Degree (e. g.

Biotechnology, Biology, Pharmacy, CTF )

Experience

- Previous experience in Quality Assurance is mandatory (3+ years)

- Previous experience with ATMPs is a plus

- Previous experience with sterile products

- Previous experience in environmental monitoring, safety methods and mediafill activities