Specialist Quality Systems
QLS are recruiting for a Specialist Quality Systems to join a Global Biopharmaceutical company based in Schaffhausen on a contract basis until the end of the year but likely to be extended.
Job Responsibilities:
- Compliance with the GMP, EHSand SOX requirements and guidelines, which are connected to the respective function.
- Ensure compliance with current and proposed Company and regulatory requirements in regards to records of NC/CAPA, Commitment and Escalations (User Access, Training, Support)
- Ensure compliance with current and proposed Company and regulatory requirements regarding site KPIs and Metrics (assure timely reporting of KPIs and Metrics).
- Support deployment of global led NC/CAPA enhancement projects
- SMEfor NC/CAPA in internal and external inspections as required
- Support Company, Company and/or regulatory inspections for the campus
- Other duties according to supervisor's instructions
- Support Site System/Process Owner for local NC/CAPA & Commitment Process/System
- Support Site System/Process Owner for local Escalation Process/system
- Responsible for providing and evaluating various site KPIs and Metrics
- Ensure compliance with current and proposed Company and regulatory requirements regarding site KPIs and Metrics (ensure timely reporting of KPIs and Metrics)
- Support deployment of globally/locally led NC/CAPA enhancement project
- Conduct Classroom Trainings, assist end-users on daily business questions
- SupportCompany, Company, and/or regulatory inspections for the campus
Candidate’s Requirements:
- Proven Quality Systems experience required
- Familiar with quality tools and problem-solving techniques
- You will have experience with GXP standards and regulations
- Exceptional communication skills to allow you to work effectively across various levels and teams
- Strong documentation and communication skills in German and English
- Proactive, independent, and committed, with a can-do attitude that will enable you to build effective relationships and networks locally/regionally.
- You will be able to make complex issues clear and transparent and be a strong problem solver.
- You will have wide Quality Systems experience andbe able to work effectively across many different functions
- You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player
- Professional knowledge of both English and Germanis a requirement
Apply:
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56722 in all correspondence.
