- Active participation in Quality system processes, such as GMP documentation management, change control, qualification and requalification activities and others;
- Maintaining and compiling GMP documentation such as specifications, analytical procedures, risk assessments, different reports, questionnaires and other;
- Evaluating GMP documentation in line with the applicable GMP guidelines and files approved by regulatory authorities;
- Ensure ongoing abidance by industry regulatory and quality requirements;
- Drive improvements in Quality Documentation and processes;
- Inspect data to detect areas for improvement;
- Presenting results and monthly key performance numbers
- Worldwide communication with Group-owned production sites and contract manufacturers
- Performing other tasks at the order of direct superior
Key Competencies Required:
- Other required professional knowledge, skills and experience
- University degree in pharmacy, biology, chemistry or comparable course of study
- English language – B2 mandatory, C1 level advantage
- Advanced level of knowledge of MS Office package
- Good communication and negotiation skills, Rapid learner and easily adaptable to changes
- Ability to work in a fast-paced, dynamic environment
- Ability to understand and discuss complex topics, technical writing skills