Beschreibung
Equipment, Facilities, Engineering Cleaning SME - Solothurn, Switzerland
Experience:
- Minimum of 5 years experience in cleaning of product.
- Minimum of 5 years experience in clean room praxis.
- Minimum of 5 years experience in laboratory and tests for cleanliness of metal implants.
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO required.
- Proficient in the use of spreadsheet software (Access/Excel etc.)
- Degree in Engineering, Chemistry Bsc
- Experience Medical Device, FDA - must
- Product Knowledge of cleanliness
- Knowledge of Zone Concept (clean room etc)
Subject Matter Expert (Equip & Facility Eng Cleanliness):
Duties and Responsibilities:
- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Develop the new Standard for Inspection Planning on statistic on the EU and eventual the Golden Standard sites.
- Consultancy and guidance of all employees and manager regarding clean room and cleaning practices.
- Consultancy and guidance of all employees and manager regarding Cleanliness of finish products.
- Consultancy and guidance of all employees and manager regarding zone concept.
- Be willing and able to travel domestically to other Legacy client EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written.
- Chemistry background.
- Support or/and generate URS.
- Good communication skill.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
- Be able to manage effectively multiple priorities and tasks.