CSV Consultant_Prague location

Accenture Services, s.r.o.

Place of work
Prague
Contract type
full-time
Wage (gross)
n/a

Information about the position

Job description, responsibilities and duties

Responsibilities:
  • Escalate non‐compliance and alignment / resolution of fundamental CSV compliance issues
  • Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
  • Support Project Manager to ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
  • Ensure project team complies with the methodology and SOP and uses the correct tools
  • Support audits and inspections to demonstrate that the projects have been managed in a compliant manner
  • Ensure completeness and consistency of project life cycle documentation
  • Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
  • Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
  • Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP
  • Train and coach project team members on achieving quality in project deliverables (e.g. project related risks are managed, issues are resolved and SOP requirements are complied with)
  • Participate in the project handover process to ensure that the project is properly handed over to Business and Support organization, including ensuring proper completion of the Handover Checklist
  • Drive tollgate reviews with Project Manager and key project stakeholders

Employee perks, benefits

n/a

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

  • Knowledge of following regulations: GxP, 21 CFR Part 11
  • Knowledge of following best practices: System Development Life Cycle, GAMP
  • Knowledge of ERP (SAP/JDE)
  • At least 10 years experience in the IT area in a technical or management role and 5 years in the Computer Software Validation area in any role
  • Able to manage direct relation with stakeholders and project team members
  • Proactive approach
  • Results driven oriented
  • Good communicator in oral and written format
  • English proficient, any additional language is a plus

Req. Code : 00315057
Division/Department : Accenture Technology

Advertiser

Brief description of the company

Accenture’s Services workforce is a dedicated team of people who work on outsourcing engagements. These are long-term partnerships with clients for whom we manage and provide increasingly specialized business operations, such as finance and accounting, IT, applications development and maintenance, help desk services, and HR. We not only maintain key business functions for clients, we constantly seek to improve them to help our clients move ahead of the competition.

Number of employees

1000 and more employees
ID: 2240607  Datum zveřejnění: 1.9.2015  Nabídka práce je převzata z jiné stránky nebo zdroje. Základní složka mzdy (brutto) a další odměny: n/a
Všechny
nabídky práce Přihlásit Vytvořte si
životopis