Reference Number: JO-2106-469990
Job Type: Permanent
Location: Frankfurt am Main
To oversee and coordinate packaging and storage/distribution projects at CCSM. To ensure that the storage and packaging area is in accordance with all GxP, company´s SOPs, guidelines and other work instructions.
To take responsibility and tasks of Leiter der Herstellung (Head of Manufacturing)
EU Director Operation.
Qualifications and Experience :
-Extensive experience in the pharmaceutical and biotechnology field
-QA and GxP competency (GMP, GDP, GCP, GCLP)
-General knowledge of IATA/ADR regulations
-Ensure that departmental standard Operating Procedures (SOPs) and Work Instructions (WIs) are written and timely reviewed and approved.
-For all packaging and distribution projects, ensure GxP requirements and all relevant local guidelines are followed for all OPS activities associated with each project.
-Organize, coordinate and validate packaging and labelling processes.
-Coordinate shipping/distribution projects.
-Ensure that all technical equipment and processing is accurately qualified and validated.
-Perform GMP and Hygiene’ Training of employees of OPS, as appropriate.
-Direct leadership function.
-Knows, understands, and complies with the companys standard operating procedures and policies.
-Performs other related job duties or responsibilities as assigned.
-Ensure that a proper disaster recovery plan is in place for the operations departments.
-Ensure, if necessary for the operations activities, that project-specific WI are produced according to the Project Coordination Worksheet/Project Plan and/or TA
-Manage the team of departmental managers and ensure that appropriate staff is hired and trained according to the needs
-Takes responsibility for personal and team skill development in continuing to learn current pharmaceutical standards and industry trends.
-Ensure that an efficient organisation and planning of activities is established for each department
-Follow the KPIs of each department
-Control the proper planning of operation activities to meet customer requirements
-Organise an efficient communication on the timeline and progress of the project, between the department managers and the project managers
-Maintain up to date know-how and expertise regarding new technologies, techniques and/or activities relating to CCSM
-Ensure a regular reporting to the VP EU Operations and to the operations teams
-Report operational data for managerial and strategic decision making to the Board of Directors.
-Organise regular meeting with the operation teams
Pharmacist´s degree or other scientific degree if excellent experiences in Clinical Supplies Management area including GMP/GDP with experience in.
Fluent in German and English. Any additional language is an asset.
If you are interested, then apply or email directly at email@example.com