Main Responsibilities
* Performs system life cycle activities such as periodic access reviews and system audit trail reviews for laboratory equipment.
* Coordinates/supports timely and effective completion of QC equipment related investigations, change controls, and CAPA's.
* Performs updates of equipment related technical documents such as SOPs, Work-Instructions, and forms.
* Supports equipment/system qualification and validation activities.
Who we are looking for
* Extensive technical know-how of QC Lab equipment (computerized and non-computerized) and corresponding system life cycle activities such as periodic reviews.
* Minimum 10 years of relevant industry experience.
* Proven experience in equipment system life cycle activities, equipment qualification, and system validation in a GMP environment. Good knowledge related to regulatory environments in the life science industry (GAMP 5, 21 CFR Part 11).
* Experience with processing of QC equipment related non-conformances, CAPA's, and change controls.
* Know-how of commissioning, qualification, validation requirements, and system life cycle activities according to c(GMP) regulations in a laboratory environment.
* Must be well organized, a self-starter, results-oriented individual with the ability to multitask in a fast-paced team environment with attention to detail and good documentation practices.
* Good verbal and written skills in English; German is a plus.
* On-site presence is required.
Duration: 4 Months
Location: Bern - On-site Required.
Please do not hesitate to contact me directly if you believe you are interested and believe you are a good fit:
Alba Jansa: alba.jansa(at)experis.ch
Whatsapp Business: +41 76 811 63 99
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