Beschreibung
For a project in Solothurn, we are looking for a
Subject Matter Expert - ACCEPTANCE PROCEDURES
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. Make recommendations to achieve compliance where shortfalls are found. Provide Audit reports as directed. Perform analyze and define Inspection Plan as necessary. Generate Inspection Plan as necessary. Background on statistics. Background on validation. Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines. Generate DCRs/DCOs that these achieve the regulatory and the business requests. Fluent German spoken and written; English is an advantage Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.) 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. Travel required form site to site. Be able to manage effectively multiple priorities and tasks. Experience:
Minimum of 4 years quality planning Compliance experience in the medical device. Prior experience in medical device/pharmaceutical remediation preferred. Familiarity and interaction experience with regulatory auditing bodies preferred. Documented training in FDA QSR, ISO required. Proficient in the use of spread sheet software (Access/Excel etc.) Engineering, Manufacturing Degree BSc Are you interested in this position? We are looking forward to receive your application. Many thanks.
