Jobbeschreibung
Tentamus Group is a global product and safety firm with a core presence in Europe, UK, Israel, China and the USA. Tentamus tests and consults on products involving the human body with strong focus on food, nutraceuticals and cosmetics. Tentamus is represented in over 90 locations worldwide with more than 4,000 highly trained staff members.
Summary/Objective:
Our laboratory is currently looking to fill a full-time position for an IT Quality Assurance Analyst (m/w/d).
As a team member, you will be responsible for establishing the Quality Culture within the IT department. You are going to support our teams by providing trainings on the Quality Procedures established in the company. Overseeing/ Approving the validation activities. Help us to stay up to date with IT Regulations in GMP and non-GMP industry. This role will collaborate cross-functionally with IT, QA and CSV teams. You are driven by improvement and are aiming success thinking in a bigger picture for business.
- In-depth knowledge of cGMP regulations and IT Quality Assurance practices.
- Strong organizational and documentation skills.
- Excellent analytical and problem-solving abilities.
- Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections and provide compliance for IT activities.
- Proficiency in using Quality Management software and tools.
- Ability to work collaboratively with cross-functional teams.
- Development and implementation of quality standards including SOPs and processes for IT products and services
- Responsible for Assessment of the Regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes review of major/critical observations from other Tentamus sites and implementation of CAPA as appropriate. Requirement for sites to remain inspection ready at all times.
- Identify, communicate, and manage trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders
- Provide compliance input to the preparation for internal management reviews, external regulatory and internal AZ inspections as required.
- Drive the continuous monitoring, improvement and digitalization of our processes, services and tools, through applying LEAN thinking and techniques, and exploiting tools and automation.
- Utilize your compliance experience to provide direction to programme/project/service managers and system owners, in the development of a risk-based approach for the delivery of compliant IT solutions.
- Bachelor's or master's degree in computer science, Pharmacy, Engineering
- At least 2 years of professional experience in an IT Quality Assurance role.
- Proficiency in handling IT QA SOPs, implementing Quality Policies, providing Trainings to the Users within the IT and Tentamus Laboratories.
- GMP experience is a plus.
- Good communication skills as a collaborative team player in across-cultural and cross-functional environments. Ability to synthesize and communicate complex concepts and analyses in an easy-to-understand way.
- Written and oral fluency in English and German is must
Travel
Travel is expected and may occasionally occur for educational/career development purposes.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the
- Challenging tasks, a motivated team, and long-term prospects in a healthy owner-managed family business
- A motivated team, flat hierarchies, and a very family-friendly working environment
- Individual training offers (Tentamus Academy) and the opportunity to help shape the growth of a medium-sized company
- Joint team events and leisure opportunities