LEGACY REVIEW SPECIALIST

CH  ‐ Vor Ort
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Schlagworte

Beschreibung

LEGACY REVIEW SPECIALIST

our multinational client in Switzerland is currently looking for a Legacy Review Specialist to join its team.
Only English is required, other languages will be a plus.
We can offer you a contract until the end of the year renewable on a long term basis.

THE ROLE:
*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

YOUR PROFILE:
*Be versed in the process validation methodology, NCR, CAPA, inspection and calibration.
*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.
*Proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters *Ability to travel, to perform internal audits and be able to work independently - with minimal supervision *Degree in Engineering (Mechanical)
*Able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
*Able to manage effectively multiple priorities and tasks.
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.

YOUR 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

If this sounds like your next challenge, send us your CV and we will call you to discuss it in more details.

Start
ab sofort
Dauer
6 months + ext
(Verlängerung möglich)
Von
Edelway
Eingestellt
27.06.2013
Projekt-ID:
557664
Vertragsart
Freiberuflich
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