Mitarbeiterin Compounding im Drug

Compounding employee at the Drug Product Clinical Supply Center (LSB) – BS

Project : For our customer, a large pharmaceutical company based in Basel, we are looking for a Compounding employee in the Drug Product Clinical Supply Center (LSB)

Tasks & responsibilities:

* Preparation and follow-up as well as production of the bulk solution to carry out the sterile filling of clinical samples, guarantee of a cGMP-compliant procedure of the process as well as cGMP-compliant documentation (e.g. process regulations, batch documentation, MES)
* Preparation: detailed planning of activities and close consultation with colleagues, wall sterilization, Cleaning of the manufacturing equipment, line clearance, operation of the ancillary systems (autoclave, filter testing device, bag freezer, Freeze Thaw, shaking water bath, IPC devices, etc.), control and preparation of auxiliary materials / active substances and equipment / disposables, filter test.
* Implementation: Operation of the systems (Ruland, Freeze Thaw, scales etc., containers), pooling, filtering, bioburdening and analysis sampling, implementation of IPC / PRC, media sampling, PI monitoring, batch-related microbiological monitoring activities
* Follow -up: filter test, line clearance , Cleaning of plants and equipment, CIP / SIP / DIP, CA samples
* Preparation and post-processing of materials
* Implementation of dispensing
* Implementation and support of compounding-specific system and process deviations, changes including creation and revision of documents
* Implementation and support with compounding-specific projects and optimizations including creation and revision of documents
* Close cooperation with internal interfaces (filling, planning & logistics, workshop, formulation development, quality assurance, etc.)

Must haves:
* Completed vocational training, bachelor’s degree or a comparable degree with a
scientific or technical background (pharmacy, biosciences,
natural sciences, engineering etc.) (*****)
* Min. 1-2 years of experience in the aseptic production of bulk solutions (compounding)
of parenteral drugs in the cGMP environment (*****)
* First experience in documentation (*****)
* Secure IT knowledge in MS Office, Google Applications and MES; Knowledge of SAP,
Trackwise, Veeva an advantage (*****)
* Very good spoken and written German is a must, English is an advantage
* Enthusiasm for the aseptic solution production of groundbreaking
* Therapies in clinical development
* Very high communication skills and interface skills
* Flexible, independent way of working in a complex environment with a high degree of
initiative
* Analytical, solution-oriented, team-focused thinking

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Reference No .: 920817RSI
Role: Compounding employee in the Drug Product Clinical Supply Center
Industry: Pharma
Place of work: Basel
Workload: 100%
Start: 01.12.2021
Duration: 6 ++
Application deadline: 08.11.2021

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