CSV Analyst - CSV Engineer, Pharma, 21CFR, OECD17

CSV Analyst - CSV Engineer, Pharma, 21CFR, OECD17

Job Purpose:

Reporting to the Computer Systems Compliance Team Leader and working within the Quality Function, the CSV Analyst is responsible for:

• The validation of computerised systems in a GxP environment and the development and delivery of CSV documentation including Risk Assessments, Validation Plans, User Requirements Specifications, Installation, Operational, and Performance Qualification Test Protocols, Traceability Matrices, and Summary Reports
• Maintain/Track/Improve computer system compliance within the company
• Assist the Director of Computer System Compliance to Influence and enforce Global Policies, Procedures, Standards, Guidelines and Templates to support the validation of business solutions
• Provide CSV expertise and risk analysis in order to agree the validation approach, if any, for projects and change control requests

This job contributes to organizational success by:

• Lead projects on behalf of the business in accordance with defined methods and standards, according to applicable regulatory guidelines (OECD 17, FDA, EU Annex 11, PICs, MHRA Data Integrity etc ).
• Identify regulatory compliance risks and proactively work with the business and IT to address them
• Develop, or oversee the preparation of, key validation deliverables (User Requirements Specifications, Validation Master Plan, IQ, OQ, PQ, Validation Summary Report, etc)
• Support and maintain validation/qualification state of existing systems through Change Control
• Perform Vendor Audits and site assessments
• Work with project managers and team members to define project plans, timescales and budgets.
• Accurately report project status to senior project team members.
• Assist with developing Standard Operating Procedures in support of CSV and regulatory compliance (Information Systems Security, User Application Permissions, User Access & Administration, Disaster Recovery, System Administration, etc)
• Maintain knowledge and develop greater understanding of system development and validation activities with a GxP environment.
• Support corporate quality and improvement processes.

Job Requirements:

• Proven experience working in a Pharmaceutical, Chemical, biotech or other highly regulated industry.
• Good understanding of system compliance regulatory requirements and guidelines (OECD 17, FDA, EU Annex 11, PICs, MHRA Data Integrity etc )
• Exposure to/working knowledge of systems such as Laboratory Systems (eg Empower, Analyst, EMKA), LIMS (eg Pristima, Labware, Debra), Document Management Systems (eg Documentum, SharePoint).
• Proficiency in both verbal and written communications and possess a high degree of personal integrity and interpersonal skills
• Leadership and teamwork skills
• Strong problem solving, analytical, technical acumen and organisational skills