QA Expert

For our client in Stein, we are seeking a QA EXPERT:

Start Date: Mid-June

Duration: 6-9 months

Location: Stein

Language: English & German

Overview of the role:

- Ensure GMP and regulatory compliance within ChemOps CH and its suppliers
-Review and approve GMP documents, eg validation, qualification, change, deviations, master batch records, testing monographs, and supplier qualifications
-Perform batch release decision in SAP.

Major accountabilities:

-Maintenance and adherence to cGMP and SOPs
-Support, as a rapporteur, of the preparation and follow-up of inspections by health authorities, customers and GQO
-Review and approval of batch-, product-, project-related GMP documents
-Guidance and support of ChemOps CH regarding GMP
-Day-to-day GMP support and -interpretation, eg in a PU
-Author/develop Modules for NVS Quality Manual
-Support of launch products by involvement in project groups
-Ensure an adequate level of education, GMP knowledge & personal competence (active & passive)
-Develop/author SOPs related to QA/QC
-Day-to-day coordination & communication with external functions, eg Experts from other ChemOps sites, SCM, TRD, ISL, REG-CMC
-Local & global project participation
-Assurance of work according to safety and ecological guidelines
-GMP Compliance System owner
-Take decision in the framework of existing processes
-Ensure adequate level of GMP-education, -knowledge & -competence by contributing to the GMP-training and by devising/supporting special quality initiatives (eg IQP).

Michael Bailey International is acting as an Employment Business in relation to this vacancy.