Beschreibung
A Pharmaceutical Client is searching for a: C&Q EngineerTasks:
* In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that:
1) Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities;
2) Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
* Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
* Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
* Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
* Coordination and oversight of external suppliers
* Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics
Qualifications:
* Bachelor/Master Degree in technical or natural sciences
* A minimum of 3 years of working experience within pharma company in C&Q equivalent position
* Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
* Know-how of quality assurance principles and experience working with cross-department stakeholders
* Excellent communication skills
* Analytical thinking and problem-solving ability
* Business fluency in English
* German language is a plus
* Self time management
Michael Bailey International is acting as an Employment Business in relation to this vacancy.