Systems Validation
Vor 3 Tagen
Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for a :
Systems Validation & Solutions Specialist
Main Activities :
- Contribute to the implementation and the maintenance of industrial computerized systems
- Be a single point of contact regarding automated systems, as a system owner :
- Create the right monitoring and performance conditions
- Advice and support the business for the software and validation scope
- Define period review and right maintenance strategy, execute activities in that regards
- Deliver required SOP, train, and keep the systems documentation up to date.
- Manage and validate the computerized systems (CS) and automated systems (AS) within the company
- Execute the validation of computerized systems and automated systems and support the activities of the team under supervision
- Implement continuous improvement in the management of CSV activities
- Write and update instructions, procedures, and documentation necessary to control the CS Develop protocols and IQ/OQ test sheets for software validation
- Serve as a reference for system validation during internal and external audits
- Take charge of any other specific mission that could be assigned by management
- Respect and enforce safety rules and current instructions
- Report any risk situation to your manager or colleagues without delay
- Ensure not to expose colleagues to dangerous situations
- Use the collective and individual protection measures necessary for the activity
- Enable and create automation, monitoring capabilities to ensure the safest business and employee working conditions
- Undertake any other specific tasks assigned by the management
Your Profile :
- EPF, HES, or University IT / Engineering degree
- 2 to 5 years of experience in a similar CSV Specialist position in life science industry
- Experience in manufacturing processes, maintenance and investigations, industry 4.0.
- Ideally knows supervision systems, industrial communication protocols and networks.
- Good experience in commissioning and system qualification
- Pedagogue, communication skills and good writing skills
- Strong organizational, communication, and interpersonal skills
- Dynamic, agile / flexible and positive attitude, with the ability to thrive in a resource-constrained environment
- Effective problem-solving skills and solution oriented, especially in complex scenarios
- Good knowledge of GMP environment, of Quality processes (change control, deviation management, risk-based approach)
- Fluent in both French and English
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