Bosontech IT Services Private Limited
Website:
bosontech.in
Job details:
Position : Computer System Validation
Experience : 6-8 years
Job location : Noida
Email : akash.sharma@bosontech.in
Job Description
- Decommissioning of systems Main Technology.
- Validation/QC expert with solid knowledge on Computer System Validation aligned with regulatory guidelines.
- Knowledge in full software life cycle (V-Model) including determining| developing| and implementing test strategies| test cases & related system documentations.
- Experience working with GxP requirements. Experience in decommissioning of systems both GxP and non-GxP Ability to work independently and drive decommissioning of systems in innovative ways.
- Provides an industry view and insights on CSV to help drive efficiency/best practices. Good written and verbal communication skills Stakeholder management.
- Validation & Regulatory compliance experience in R&D for a pharma company .
- Acts as liaison between Quality Assurance and the system management to assure that the GxP system meets the Quality & Compliance requirements as per NN QMS procedures and regulatory guidelines. Participate in system releases while performing Validation Responsible role.
- Authoring/ Reviewing IT Risk Assessment| Implementation Plan and Report| Functional Requirements| Design Requirements| Test coordination / Validation and Defect Management| etc| meeting the Quality & Compliance requirements as per NN QMS procedures and regulatory guidelines.
- Support System Manager on the system management activities as and when required.
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