Neben privaten Reinigungsfrauen und -männer gibt es auch ganze Putzkolonnen, welche von einer eigens gegründeten Reinigungsfirma angestellt sind. Zur Reinigung zählt das Putzen und Aufräumen von privaten oder gewerblich genutzten Räumen und Gebäuden. Es gibt in der Schweiz auch Stellenangebote für die Gebäudereinigung, da die Stellen der Reinigung oft unter diesem Begriff zusammengefasst werden. Je nach Auftraggeber gehört zu diesem Beruf auch das Waschen, Abwaschen und Putzen von Fenstern. Oft werden Leute in der Reinigung für Schwarzarbeit gesucht, was jedoch vor allem versicherungstechnisch riskant ist.
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Sterility Assurance Specialist
Responsible for the Europe implementation and management of sterility assurance and reprocessing. Ensures compliance to the applicable Medical Device Regulation (MDR), ISO 13485, ISO14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization and reprocessing process.
Additionally, to other applicable Sterilization, Cleaning, Disinfection and Microbial ISO and EN standards, AAMI standards/reports and other guidance documents as required. Provides SA oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the European manufacturing system. This should be accomplished by working closely with the Product Development (PD).
Tasks & Responsibilities:
Review, establish, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs. Ensure the development and implementation of harmonized practices/procedures
Review and develop reprocessing strategies and processes. Review and analyze medical device drawings. Validate all microbial aspects of new products and packaging. Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production. Develop and validate cleaning, disinfection and sterilization processes for existing and new products.
Build internal validation protocols and reports. Review external ones to ensure company and regulatory requirements are met. Ensure sterility validations (dose audits, EtO validations…) for all product families are maintained. Implement the microbial assurance aspects of the Quality System
Investigate non-conformities and CAPAs related to sterilization and contamination and build reports that are consistent, complete and in alignment with applicable standards and procedures including appropriate content and references.
Drive compliance to the applicable Medical Device Regulation (MDR), ISO and FDA (QSR) regulations as they apply to sterilization. Additionally, to other applicable Cleaning and Disinfection standards/reports and other reference documents as required.
Be well versed in government regulations and industry guidelines for cleaning and sterilization (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
Coach other business groups, consultants and other personnel in basic reprocessing and sterilization procedures. Correspond with customers with special requests regarding the Synthes sterilization/cleaning program
Perform regular internal auditing of product development and provide audit support. Conduct technical assessments of contract sterilizers and laboratories
A Bachelor of Science Degree is required. A Master of Science is preferred. 2- 3 years practical experience are of advantage
Experiences in support of medical devices delivery, biology, pharmaceutical, or similar regulated industry is preferable
Knowledge of FDA and MDR GMP requirements or standards regarding Medical Devices
Experience with GMP environments, particularly sterilization processes, microbiological testing is preferred
Good social, organizational and communication skills. Comfortable to work with cross functional teams
This position requires a high level of written and oral communication skills and the ability to
interact with managers at all levels as well as personnel at the operating unit level.
Excellent organizational skills and multi-tasking abilities preferred
Fluent in German and English is preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.