Offre: validation specialist (c&q engineer):Randstad.ch
. 25. juillet 2021
. bern, berne
. life sciences
. réka szitter, zurich professionals it
. 058 201 56 60
description du poste
Validation specialist (CQ)
Are you a validation specialist in commissioning and qualification engineer with professional experience in the pharma industry?The office is situated in the beautiful Kanton Bern at one of the many branches the company has all around Switzerland.As the world?s largest and most broadly-based healthcare company in the world, with a broad range of products from consumer health care, medical devices to pharmaceuticals. This American company can truly open a great career opportunity for you! Tasks and responsiblities
. In charge of commissioning and qualification (C&Q) activities for echnical 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 con-conformances related to qualification topics
. This role is main objective is to perform activites related to thermal mapping and autoclaves.
. 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
. Knowledge 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
Have we sparked your interest? Please, do not hesitate!
We are looking forward to receiving your completed application.