Process Expert Manufacturing (m/f)

REFERENZNUMMER:

330655/11

IHRE AUFGABEN:

-Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements
-Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution
-Review and assure that validation protocols and report are technically correct
-Execute process improvements, scale-up
-Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
-Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality
-Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product
-Lead product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
-Provide training for assigned new processes and products
-Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit

IHRE QUALIFIKATIONEN:

-BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree, desirable MSc. or equivalent experience
-Experience in the pharmaceutical industry
-Experience in manufacturing of dosage forms is beneficial
-Fluency in German and English

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist