Remote Work No
Senior Product and Validation Expert
Location: Onsite in Vienna, Austria
Albion Rye Associates are proud to be partnered with a global leader within the pharmaceutical industry who are at the forefront of R&D and Innovation within medications and vaccines.
- End to end responsibility for specific product(s)/product group(s)
- Project management as the product expert
- Permanent optimization of production processes (granulation, tableting, coating of tablets, mixing)
- Evaluation and implementation of process changes, alternative suppliers for APIs (Active Pharmaceutical Ingredients), and selection of production facilities with regard to new technologies
- Implementation of product transfers, design of experiments (DoEs) and execution of test batches, definition of process parameters
- Owner of change requests, CAPAs, and events, preparation of registration documents
- Contact person for authority inspections (FDA, AGES…) regarding process validations and production processes.
- 4+ years’ experience in process validation within the Pharmaceutical Industry
- Experience with Product Transfer, Process Transfer, process changes and CAPA
- Experience in project management and/or as a process optimization expert is strongly preferred.
- Completed technical or scientific studies required.
- Several years of experience in the pharmaceutical industry as well as experience in process validation
- Can speak German and English
- Experience with regulatory inspections
- Knowledge of the production processes of solid dosage forms an advantage.
- Problem-solving skills, personal responsibility, and decision-making ability.