Due to changes in GDPR and increased usability with the website, any candidates registered before 03/05/19 will need to re-register
Hyper Recruitment Solutions
Back to results

CSV Contractor - Japan

Experience Dependant
Job Reference: J5631804
Updated On: 07/11/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology

Skills: Quality Assurance - Contract, IS&T - Systems Engineering, Quality Assurance - Compliance, Quality Assurance - CSV, IS&T - Data Integrity

Job Information

Role Overview

This is an opportunity for an experienced Computer Systems Validation (CSV) / Quality Assurance Consultant to join an innovative Pharmaceutical organisation in Japan.

As the Senior CSV Consultant you will be responsible for providing Quality Assurance review and approval of CSV / SDLC deliverables within a Pharmaceutical environment for a global SAP platform.

Key Duties and Responsibilities

Your duties as the CSV Consultant will be varied however the key duties and responsibilities are as follows:

1. You will provide Quality Assurance Review and Approval of Computer Systems Validation (CSV) / Software Development Life Cycle (SDLC) deliverables in a timely manner.

2. Your primary role will be providing expertise for GxP aspects of the Global SAP Platform (System/Application), Infrastructure, solution manager, test management and training tools as well as GxP interfaces.

3. You will participate in project meetings, and evaluate issues to the Project Lead for the SAP Platform as necessary.

4. You will be responsible for assessing Vendors and Service Providers for GxP Compliance, SDLC/CSV, including Good Automated Manufacturing Practice (GAMP5) and establishing Quality Agreements as necessary.

Role Requirements

o be successful in your application to this exciting opportunity as the CSV Consultant we are looking to identify the following on your profile and past history:

1. Relevant degree or equivalent

2. Proven industry experience in the Pharmaceutical industry is essential.

3. A working knowledge and practical experience with SAP / ERP System Validation activities, CSV, SDLC, GAMP5
Georgia St John-Smith
Your Recruitment ConsultantGeorgia St John-SmithGeorgia.smith@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.