München
Activities:
* Identification, establishment and improvement of innovative approaches of formulation concepts
for a wide range of dosage forms
* Development of formulations that meet customer needs
* Clinical samples and approval batches production
* Ensuring timely production and monitoring of manufacturing activities in accordance with AMG,
AMWHV and EU-GMP guidelines
* Ensuring and checking the correct batch documentation and other quality records
* Implementation and documentation of process validations
* Ensuring the correct processing of deviations, initiating corrective measures
* Implementation of CAPA measures from deviations, customer complaints, audits, etc.
* Approving and monitoring the changes as part of the change control process
* Representing the area of responsibility to customers and authorities
Profile:
* Degree in the field of pharmacy, biotechnology or a comparable discipline
* 5+ years of professional experience in the pharmaceutical industry with in-depth experience in
formulation, process and packaging development of pharmaceutical dosage forms
* Leadership experience and very good motivational skills and an authentic leadership style
* Very good knowledge of official regulations (German and European guidelines, FDA, etc.), GMP
regulations and other relevant legal requirements (AMG, etc.)
* Fluent in German and English
* Strong quality awareness and good computer skills
