Process Engineer - Qualification Coordinator / Compliance Expert (m/f)

REFERENZNUMMER:

293495/11

IHRE AUFGABEN:

-Support the Project Manager (PM) or the PU engineering team with regard to computer system validation and equipment qualification issues
-Draw up documents and forms to be used within the Project
-Supervise the compliance with fundamental GMP-requirements in cooperation with the QA user (QA Q/V, QA CPL within PU)
-Issue SOPs and FRMs (project specific)
-Coordinate and finalise fundamental GMP-relevant documents (e.g. QNA, GMP Risk Analysis, QP, RN, QR etc.)
-Coordinate standardisation of GMP-relevant documents and activities to be provided by suppliers (e.g. document list and forms)
-Support the PU engineering team in maintaining the life cycle documentation of all installations up to date
-GMP compliant project execution and life cycle documentation

IHRE QUALIFIKATIONEN:

-Degree in pharma, chemical, mechanical, process or electrical engineering (Dipl. Ing. or M.Sc. or B.Sc. or equivalent)
-Good knowledge of German and English
-Experienced in qualification activities within the pharmaceutical industry
-Extended GxP/QA knowledge
-Project experience regarding mid-sized investment projects with medium complexity (responsibility for time schedule, costs, functionality and quality)
-In-depth technical knowledge in chemical or pharmaceutical or infra engineering

WEITERE QUALIFIKATIONEN:

Quality manager, Compliance manager