Beschreibung
Leading Biopharmaceutical manufacturing plant currently has a contract requirement for an experienced QA Specialist.
Tasks/objectives:
1.Improve "Shop Floor Oversight" (Quality on the Shop Floor):
This Project would include "hands on" assistance with the development and implementation of a formal program that would improve quality on our shop floor at our facilities. Examples include: Compare "practice vs. procedure" of Batch Production Records (BPRs) and Standard Operating Procedures (SOPs), DRAFT required changes to reduce variability, process documentation changes through Change Control process, train operational personnel as applicable, and implement revised documents.
2.DR Reduction:
This Project would include "hands on" assistance in the evaluation and "ghost writing" of Deviation Reports (DRs) at the client`s Site. This includes the evaluation of DR investigations relating to the production of all vaccine and biological product batches produced at the Site; the support, coaching and mentoring of client`s personnel involved in the timely execution of the Deviation Management Process in accordance with approved SOPs.
Qualification:
-Bachelor or Master of Science (Biology, Biotechnology or Chemistry) or Engineering degree (chemical engineer, process engineer)
-Experience in Pharmaceutical industry
-Experience in documentation of deviations and changes
-Good command of English language
- German language skills are a plus
This is an exciting opening to work in dynamic team in long term contract opportunity. Please apply now for more information.