NRW, Germany
Job Description:
* Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents
as it relates to the Fill Finish Operation.
* Comply with GMP regulations by strict adherence to departmental policies and procedures and timely
accurate completion of records as needed.
* Support the management and development of improved and new processing techniques in the various
aseptic processing activities.
* Provide technical support to production staff involved in the various aseptic processes
* Troubleshooting and technical support into process investigations
* Facilitate deviation initiation , be responsible to investigate the issue, propose and execute CAPA
* Facilitate/responsible of the change control process.
* Work effectively with QA/QC, manufacturing, facilities and other support staff personnel
* Support or lead Tech transfer projects from receiving site.
* Perform process mapping and process efficiency trending
* Provide the aseptic/process training to floor operation personnel
* Initiate and implement the process improvement projects to improve the filling efficiency and reduce the cost
* Support validation and engineering project as production final user
* Support BR review
* Owner process related BR incl. improvement - support PDM at CCRยดs and adjustment MBR
* Responsible for process related topics in audits
* Responsible to support the training coordinator
* Determine KPIยด s
Profile:
* Vocational training on pharmaceuticals or chemistry or comparable training
* Professional experience in pharmaceutical production, at least 5 years required
* Familiar with the design, development and improvements of APS strategies,
* Strong knowledge on aseptic working technics at isolator and RABS systems.
* Knowledge in the areas of GMP and occupational safety
* Familiar to sterile preparation production meeting cGMP
* Detailed knowledge on FDA and EMA guidelines for aseptic manufacturing in fill and finish environments
* German and English in word and writing
