Gmp Qa Officer Modena

Gmp Qa Officer
Modena
Emilia Romagna, Modena

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients.

The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products.

Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders.

Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e. g.

neurology, oncology, as well as metabolic and infectious diseases.

Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.

Evotec operates globally with more than 4, 200 highly qualified people.

The Company's 16 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

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We have a great opportunity at our Medolla (MO) site for a QA role to be introduced in the QA organization in our site for Sterile GMP production of ATMP for clinical phases.

Essential Functions

- Provide QA support to Drug Product Manufacturing and Quality Control in terms of GMP compliance;

- Perform the Batch record review

- Review paper and electronic raw data with focus on Data integrity compliance

- Write and review Standard Operating Procedures;

- Provide QA support to perform internal audits of GMP areas to measure compliance with appropriate procedures and applicable regulations;

- Provide QA support in deviations, OOS, and change management;

- Provide QA support in the manufacturing process validation, cleaning validation, process simulation

- Provide QA support in the equipment calibrations and facility qualifications

- Collaborates in the execution of internal Risk assessment documents;

- Promote and maintain a high level of GMP awareness and compliance in GMP areas.

- Maintain a high level of updating of QA documentation and records

Required Skills & Abilities

- Intermediate knowledge and at least basic background in cGMP regulation;

- English intermediate level is required (written and spoken).

- Good verbal, written, and interpersonal communication skills;

- Ability to work independently, maintaining a team-focused attitude;

- Open-minded and problem-solving attitude.

Education

- Degree or PhD in appropriate scientific area.

Experience

- Experience in a quality assurance role (3 years) including knowledge in GMP regulations working in a pharmaceutical or biotechnology industry.

- Experience in sterile drugs, particularly ATMP, is preferred.

Worker