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Legacy Review Specialist
Eingestellt von Edelway
Gesuchte Skills: Engineering, Sap
Projektbeschreibung
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 13485/9001 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.
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 13485/9001 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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik