Quality Assurance Officer ATMP (maternity replacement)

Evotec SE; Emilia-Romagna; On-site; EUR 55,000 - 75,000; Full time

Job summary

Evotec SE in Modena, Italy, is seeking a GMP Quality Assurance professional, experienced in aseptic manufacturing, to join the Cell and Gene Therapy team and ensure ATMP manufacturing activities meet company and intercompany standards.

You will help manage documentation, support risk analyses, change control, deviations/ CAPAs, training plans, supplier qualification, batch records, and batch record reviews in a compliant GMP environment.

Qualifications

• 3+ years of QA experience mandatory.
• ATMP experience is a plus.
• Experience with sterile products.
• Environmental monitoring, safety methods and mediafill experience.
• Knowledge of current GxP guidelines.
• English intermediate (written and spoken).

Responsibilities

• Manage a comprehensive documentation system for all Cell Factory operations.
• Collaborate in risk analyses.
• Collaborate in change management system.
• Manage deviations and corrective/preventive actions.
• Regularly inspect all departments for GMP compliance.
• Support the development of training plans for staff.
• Qualify external suppliers.
• Handle complaints.
• Distribute production batch records.
• Execute the Batch Record Review.
• Document management.

Skills

GxP knowledge

Team player

Organizational skills

Deadline oriented

English (intermediate)

Education

BS or MS in Biotechnology/Biology/Pharmacy

Tools

MS Office

Job description

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)
• Good knowledge of Microsoft Office applications

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

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

EN: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

IT: In compliance with fundamental ethical and professional principles and with Legislative Decree 198/2006, Evotec is an Equal Opportunity Employer committed to fostering a safe, diverse, and inclusive workplace built on mutual respect. We provide equal employment opportunities to all qualified candidates and employees based on their skills, experience, and professional qualifications. In line with our ethical and professional principles, all employment-related decisions, including recruitment and selection processes, are made fairly and without any form of discrimination. All qualified candidates will be considered for employment regardless of race, color, sex, age, disability, genetic information, gender expression, gender identity, nationality, religion, sexual orientation, or any other characteristic protected under applicable law.