Beschreibung
Sehr geehrte Damen und Herren,
möglicherweise ist folgendes Projekt für Sie oder einen befreundeten Kollegen von Interesse:
HEAT TREATMENT PROCESS ENGINEER
Location: Solothurn, Switzerland
Contract Length until
There is a high likelihood of extension until the end of 2014
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.
- 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. (will be trained on the Synthes System).
- 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.)
German: Fluent
English: Fluent
Bei Interesse und wenn Sie nachweislich in den letzten Projekten in diesem Umfeld gearbeitet haben, freuen wir uns über die Zusendung Ihres aussagekräftigen Profils/CV/Projektliste im Word-Format.
Sollten Sie selber nicht verfügbar sein, können Sie diese Stellenbeschreibung auch an befreundete Kollegen weiterleiten. Sollte sich dann eine erfolgreiche Vermittlung ergeben, bieten wir selbstverständlich auch eine angemessene Prämie.
Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
IT-Recruitment Consultant
Michael Bailey International is acting as an Employment Business in relation to this vacancy.