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