CSV Analyst

Pharmathen

. Participate in generation and execution of GMP-related documents and protocols, including URS, FS/DS, IQ, OQ and PQ .

Posted 9/17/2026full-timeSapes • GreeceJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP-related documentation and protocols, including URS, FS/DS, IQ, OQ, and PQ, while ensuring compliance with regulatory requirements and quality standards. Proficient in Computerized Systems Validation and risk management methodologies, with strong communication skills for collaboration with internal and external stakeholders.

Highest-signal resume keywords

GMP-Related DocumentationComputerized Systems ValidationValidation/Verification Protocols PreparationRisk Management MethodologyIT-QA Audits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP-Related DocumentsURS PreparationFS/DS PreparationIQ/OQ/PQ DocumentationValidation/Verification ProtocolsChange Control ManagementDeviation InvestigationAutomated/Manual Testing ScriptsSite Acceptance Test (SAT)User Acceptance Test (UAT)

Soft Skills

CommunicationCollaborationDocumentation Practices

Industry Keywords

Quality Compliance StandardsRegulatory RequirementsComputer SystemsIT Policies and ProceduresAuditing

About the role

Key responsibilities & impact

Participate in generation and execution of GMP-related documents and protocols, including URS, FS/DS, IQ, OQ and PQ
Participate in the creation, revision and implementation of IT-related policies and procedures
Assist in auditing, reviewing, developing and implementing computerized systems to ensure quality and compliance standards
Assist with computer system operation, development and validation queries during regulatory and due diligence inspections
Collaborate with departments to monitor compliance with standards and regulations governing company IT systems
Communicate with external parties, including customers and suppliers, to ensure appropriate support
Manage and support the core project team and users on a day-to-day basis
Ensure computer systems and their use comply with regulatory requirements, guidelines and current practice

Requirements

What you’ll need

BSc in Electrical Engineering, Computer Science or relevant field
Minimum 2 years’ experience in a similar role
Basic knowledge of Computerized Systems Validation—Legislation
Preparation of Validation/ Verification Protocols (URS, FS, DS documents)
Preparation of automated/ manual testing scripts (IQ/ OQ/ PQ Documents)
Participation in SAT (Site Acceptance Test)/ UAT (User Acceptance Test) Activities
Good Documentation Practices
Risk Management Methodology for Validation
IT- QA Audits for leveraging software supplier
Deviation Investigation
Change Control Management

Benefits

Comp & perks

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business/ scientific knowledge and skills
Equal opportunity employment