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CSV Engineer
Eingestellt von ITech Consult
Gesuchte Skills: Engineer
Projektbeschreibung
CSV ENGINEER
REFERENZ-NR.: 5316KS
BRANCHE: Medical
EINSATZORT: Basel und Region
BEGINN: Juni 2015
DAUER: bis Ende 2015
PENSUM: 100%
AUFGABENBEREICH:
- Understanding of software validation requirements with respect to Data Integrity, security, GAMP guidelines and the requirements of 21 CFR Part 11.
- Understanding of documentation change control, review, approval and archiving requirements and the ability to ensure procedures are efficiently and consistency applied.
- Ensure Business Processes & Validation Master Plans are established and updated where necessary
- Approve and compile where appropriate CSV protocols and reports.
- Develop templates and write/edit validation documentation as required.
- Manage the IQ, OQ & PQ process for the project team.
- Track and resolve exceptions during qualification activities.
- Prepare reports of executed protocols for review.
- Prepare and/or update standard operating procedures, Operation Handbooks and ensure they are reviewed in a timely manner with respect to CSV.
- Work closely with Quality Assurance and system owners to effectively implement system upgrades, or system modifications.
- Produce reports on validation activity, utilizing knowledge and experience to effectively communicate results to stakeholders.
- Prepare, maintain, and review validation documentation.
- Complete and review quality systems risk assessments.
ANFORDERUNGEN:
- 3-5+ years of working experience in IT Quality CSV operations or compliance
- 2-3 years test and deviation management
- Detailed knowledge and understanding of CSV, 21 CFR Part 11 and GAMP
- Excellent technical writing ability
- Good written and verbal communication and presentation skills
SPRACHKENNTNISSE: BILINGUAL GERMAN AND ENGLISH LANGUAGE SKILLS MANDATORY
REFERENZ-NR.: 5316KS
BRANCHE: Medical
EINSATZORT: Basel und Region
BEGINN: Juni 2015
DAUER: bis Ende 2015
PENSUM: 100%
AUFGABENBEREICH:
- Understanding of software validation requirements with respect to Data Integrity, security, GAMP guidelines and the requirements of 21 CFR Part 11.
- Understanding of documentation change control, review, approval and archiving requirements and the ability to ensure procedures are efficiently and consistency applied.
- Ensure Business Processes & Validation Master Plans are established and updated where necessary
- Approve and compile where appropriate CSV protocols and reports.
- Develop templates and write/edit validation documentation as required.
- Manage the IQ, OQ & PQ process for the project team.
- Track and resolve exceptions during qualification activities.
- Prepare reports of executed protocols for review.
- Prepare and/or update standard operating procedures, Operation Handbooks and ensure they are reviewed in a timely manner with respect to CSV.
- Work closely with Quality Assurance and system owners to effectively implement system upgrades, or system modifications.
- Produce reports on validation activity, utilizing knowledge and experience to effectively communicate results to stakeholders.
- Prepare, maintain, and review validation documentation.
- Complete and review quality systems risk assessments.
ANFORDERUNGEN:
- 3-5+ years of working experience in IT Quality CSV operations or compliance
- 2-3 years test and deviation management
- Detailed knowledge and understanding of CSV, 21 CFR Part 11 and GAMP
- Excellent technical writing ability
- Good written and verbal communication and presentation skills
SPRACHKENNTNISSE: BILINGUAL GERMAN AND ENGLISH LANGUAGE SKILLS MANDATORY
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik