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Subject Matter Expert (Acceptance Activities/Statistic)
Eingestellt von Berry Technical
Gesuchte Skills: Engineering, Sap
Projektbeschreibung
Subject Matter Expert (Acceptance Activities/Statistic)
CHF Negotiable
6 month contract
Solothurn
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.
- Develop the new Standard for Inspection Planning on statistic on the EU and eventual the "Golden Standard" sites.
- Well know statistics (Master-Level).
- Be willing and able to travel domestically to other EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.).
- Generate URS for new software and tools.
- 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
- Be able to manage effectively multiple priorities and tasks.
Experience:
- Minimum of 7 years experience in statistic preferred in metal industry.
- Compliance experience in the medical device.
- 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.)
Department/Project description:
- GRQP - Global Remediation and Quality Project
- Degree in Engineering, Chemistry Bsc
*Specific technical skills (please detail):
*Specific knowledge for the role (please detail):
Specific languages:
- German - fluent not a must
- English - fluent not a must
Competencies:
- Non technical/soft skills (Differentiate must-haves vs nice-to-haves)
- Team player
- Independent autonomous
- Work well under pressure
Experience:
- Experience Medical Device, FDA - must
- Product Knowledge of cleanliness
- Knowledge of Zone Concept (clean room etc)
CHF Negotiable
6 month contract
Solothurn
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.
- Develop the new Standard for Inspection Planning on statistic on the EU and eventual the "Golden Standard" sites.
- Well know statistics (Master-Level).
- Be willing and able to travel domestically to other EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.).
- Generate URS for new software and tools.
- 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
- Be able to manage effectively multiple priorities and tasks.
Experience:
- Minimum of 7 years experience in statistic preferred in metal industry.
- Compliance experience in the medical device.
- 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.)
Department/Project description:
- GRQP - Global Remediation and Quality Project
- Degree in Engineering, Chemistry Bsc
*Specific technical skills (please detail):
*Specific knowledge for the role (please detail):
Specific languages:
- German - fluent not a must
- English - fluent not a must
Competencies:
- Non technical/soft skills (Differentiate must-haves vs nice-to-haves)
- Team player
- Independent autonomous
- Work well under pressure
Experience:
- Experience Medical Device, FDA - must
- Product Knowledge of cleanliness
- Knowledge of Zone Concept (clean room etc)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik