Beschreibung
Legacy Review Specialist
CHF Negotiable
Solothurn - other locations dependant
6 month contract
Legacy Review Specialist.
- Job description/Functional experience requirements:
* 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' procedures 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 CAPA root cause and corrective/preventive action as necessary.
* Perform CAPA verification of effectiveness as necessary.
* Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
* Analyzing reports NCR, CAPA files.
* Analyzing inspection activities.
* Analyzing maintenance reports and monitoring data.
* Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
* Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc
- Knowledge & Skills:
* The resource should be versed in the process validation methodology, NCR, CAPA, inspection and calibration, as defined by GAMP, AAMI, ASQ, DePuy or Legacy Synthes. The person must be analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is required, as the special processes are generally not verifiable; thus, the validation requirement.
* The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
* The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision
- Required degree/certificates:
* Degreed Engineer (Mechanical)
- Specific technical skills (please detail):
* Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
- Specific knowledge for the role (please detail):
* Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Specific languages:
* Fluently German/English spoken and written
- Competencies:
* Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
* Be able to manage effectively multiple priorities and tasks.
* 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
- Experience:
* Minimum of 5 years quality/compliance experience in the medical device or pharmaceutical industries.
* 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.
- Unique Selling Points:
* FDA QSR, ISO 13485
* Start ASAP
PLEASE NOTE THAT THESE ROLES ARE BASED IN:
Balsthal, Bettlach, Hägendorf, Raron, Mezzovico, Oberdorf BL, Zuchwil and Selzach.