Product Technology & Transfers Expert
Helvepharm AG
Date de publication :
15 août 2024Taux d'activité :
100%- Lieu de travail :Bucharest / Zentiva
Key responsibilities:
- Ensures, through the validation process, the quality of the products in the transfer phase, with the alternative producers of raw materials and/or packaging and in the process of optimization.
- Prepares and updates part of the documentation for the registration files.
- Prepares justifications in order to support the deficiency letters received from the authorities.
- Performs technology transfer from one Zentiva factory to another. Implements new technologies and equipment for transfer and portfolio products.
- Solve problems in production, change the manufacturing process and/ or the packaging way or the packaging material, as a result of quality, market or legislative requirements.
- Coordinates through technical expertise the critical stages of the projects managed by the work team, depending on their addressability.
Requirements:
- Bachelor’s degree (pharmacy, chemistry, biochemistry)
- Minimum 3 years experience in the pharmaceutical industry
- Relevant knowledge of chemistry and pharmaceutical technology
- Knowledge and observance of RBPF standards
- Knowledge of manufacturing flow
- Ability to decide and solve problems on the production flow
- Independent thinking, adaptability, innovation, analysis skills
- Emotional balance, initiative, involvement, teamwork
- PC operating skills
- Knowledge of GMP/EHS standards
- Knowledge of technological processes and production documentation