Odmeňovanie
minimum 2.000€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company
Informácie o pozícii
Job description, responsibilities and duties
About the Role
The eCSV Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
Key Responsibilities
Your contributions include, but are not limited to:
Implementation Projects
- Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system
- Work closely with the project manager to ensure all compliance milestones are met during the project lifecycle.
- Oversee and/or assists in the development of validation deliverables including Validation Plans, TestPlans/Protocols/Scripts,Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
- Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations.
- Coach the implementation teams in the proper execution of validation documents
- Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensureinitiation/preparationand closeout of all eCSV related deviations.
- Supply accurate KPIs to management on project compliance status
System Maintenance
- Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
