Beschreibung
Subject Matter Expert -Acceptance Activities
CHF Negotiable
Solothurn, Switzerland
6 month contract
Our client is seeking an experienced Subject Matter Expert to join their team on site in Solothurn.
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.
- Perform analyze and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background on statistics.
- Background on validation.
- Be willing and able to travel domestically to other Legacy Synthes EU sites as required.
- 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 spreadsheet software (Access/Excel etc.)
Competencies:
* Non technical/soft skills (Differentiate must-haves vs nice-to-haves)
Team player
Independent autonomous
Work well under pressure
Experience:
Experience Medical Device, FDA - must
Acceptance activities - consulting, control plan
Mechanical experience