Beschreibung
Quality Manager, Teamleader QA for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- Knowledge about US law FDA, especially 21 CFR Part 4, 21 CFR 820, and combination product regulation
- Know-how of design control SOP documents such as analytics and testing, device technology, human factor engineering, risk management, covering all aspects within the lifecycle of a medical device or combination product
- Solid knowledge of regulatory requirements such as ISO 13485, MDD and MDR as well as of DHF or technical files
- Project management skillset as well as capability to mentor to transfer knowledge to associates
- Experience with SharePoint as company communication tool is advantageous
- Languages: English, fluent in written and spoken
Your tasks:
- Creating a digital Quality Management System (QMS) gap analysis based on current QMS procedures for standard operating procedures, working procedure and processes according to MDSW (Software as Medical Device and Software including Medical Device) regulations including prioritisation implementation plan
- Finalising new digital QMS implementation Prio 1 documents and procedures for SOP, working procedure according to MDSW regulations including building up an new QMS action tracker and preparing status slides deck
- Conducting a lesson learned meeting with leadership team TRD QA drug delivery systems and digital application
- Creating a Digital Quality Management System (QMS) road map for 2022 with lesson learned from 2021
Start: ASAP
Duration: 08MM+
Location: Basel, Switzerland
Ref.Nr.: BH16959
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.