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Quality Manager
Eingestellt von Ark Resourcing
Gesuchte Skills: Business intelligence, Sap
Projektbeschreibung
RESPONSIBILITIES
- Oversee the validation of the deliverables and plan quality and compliance activities
- Understand and adhere to SOP on Change Management, Document Management and Quality Management; and our clients' Group Computerized System Validation concept with regards to document management, and ICE Methodology.
- Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements
- Apply required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.)
- Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
- Collaborate with the Project Manager to execute operational changes to the system on the delivery of all defined QM documentation
- Participate in the planning of development, test and deployment phases
- Approve the final close down of a release
MAINTENANCE OF COMPLIANT STATE
- Ensure system remains in a compliant state
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
- Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation
- Ensure all relevant quality and compliance aspects are identified, managed during the development and deployment of Minor releases and emergency releases.
- Ensure all the documentation generated during a release is uploaded in official document repository
KNOWLEDGE ON FOLLOWING BUSINESS AREA:
- Logistic & Manufacturing
- Financial & Procurement
- Business Intelligence
- Quality Assurance
- Clinical Trials
SKILLS & EXPERIENCE
- 10 years in the IT area in a technical or management role
- Several years of experience in Computer Software Validation
- SAP modules
- Business Intelligence software & Middleware
- Web applications development tools
- GxP, 21 CFR Part 11, SOX and SOX IT knowledge
- System Development Life Cycle and Gamp Knowledge
- Knowledge in CoBIT, RiskIT, ITIL, ISO9000, Six Sigma will be an added advantage
- Able to manage direct relations with stakeholders and project team members
- Excellent English communication skills
- Oversee the validation of the deliverables and plan quality and compliance activities
- Understand and adhere to SOP on Change Management, Document Management and Quality Management; and our clients' Group Computerized System Validation concept with regards to document management, and ICE Methodology.
- Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements
- Apply required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.)
- Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
- Collaborate with the Project Manager to execute operational changes to the system on the delivery of all defined QM documentation
- Participate in the planning of development, test and deployment phases
- Approve the final close down of a release
MAINTENANCE OF COMPLIANT STATE
- Ensure system remains in a compliant state
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
- Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation
- Ensure all relevant quality and compliance aspects are identified, managed during the development and deployment of Minor releases and emergency releases.
- Ensure all the documentation generated during a release is uploaded in official document repository
KNOWLEDGE ON FOLLOWING BUSINESS AREA:
- Logistic & Manufacturing
- Financial & Procurement
- Business Intelligence
- Quality Assurance
- Clinical Trials
SKILLS & EXPERIENCE
- 10 years in the IT area in a technical or management role
- Several years of experience in Computer Software Validation
- SAP modules
- Business Intelligence software & Middleware
- Web applications development tools
- GxP, 21 CFR Part 11, SOX and SOX IT knowledge
- System Development Life Cycle and Gamp Knowledge
- Knowledge in CoBIT, RiskIT, ITIL, ISO9000, Six Sigma will be an added advantage
- Able to manage direct relations with stakeholders and project team members
- Excellent English communication skills
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Organisation/Management