We are looking for an manufacturing expert to manage all activities related to manufacturing of clinical supplies and provides expert support for all GMP aspects in development projects and in external and internal GMP audits.
The main accountabilities are:
•Responsible for the independent planning and supervision of clinical supply in adherence with GMP requirements and project timelines
•Delivers GMP compliant documentation and supports worldwide registration processes
•Provides front line support for manufacturing, focusing on manufacturing processes and executing each batch safely and on time, in compliance with the batch instructions and quality requirements
•Drives process related trouble shooting, leads product and process related investigations and deviations, including complaints actions
•Ensures that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
•Maintains their processes at inspection readiness level and provides the necessary support in any internal or external audit
•Ensures that all critical and significant parameters are within written instruction (i.e. Master Batch Record, Validation Plan)
•Supports the execution of process validations, re-validations and short-term improvement projects
•MSc. or equivalent (PhD desirable) in science with focus on pharmaceutical technology (e.g. Pharmacy, Chemistry, Biochemistry, Biotechnology)
•Minimum 3 years of industry experience in dosage forms development and/or GMP manufacturing of dosage forms (experience with sterile, parenteral depot and/ or topical dosage forms are desirable)
•Profound understanding of regulatory and cGMP requirements as well as expertise in the development of drug delivery systems
•Fluent in German and English (oral and written)
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.