CSV Analyst

Job highlights

• Create and maintain validation documentation,including Validation Plans,IQ / OQ/PQ protocols,URS,RTM,and other required documents
• Certification in relevant areas (e.g.,quality management,project management).
• Preferred Skills
• 5+ years of proven experience in serialization implementation within the pharmaceutical industry

Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, ICH Q9).

Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents.

Conduct impact assessments, risk assessments, and manage change control processes.

Handle CAPA, incident management, and release management activities related to Validation activities.

Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS.

Utilize JIRA for tracking tasks, issues, and project progress.

Collaborate with cross-functional teams to ensure successful Validation Documents preparation.

Stay up-to-date with industry best practices and regulatory changes related to Validation.

Qualifications

5+ years of proven experience in serialization implementation within the pharmaceutical industry.

Strong understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9).

Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM).

Familiarity with quality management systems (QMS) and SOP development.

Proficiency in using JIRA or similar project management tools.

Excellent communication and interpersonal skills.

Preferred Skills

Experience with specific serialization software and hardware solutions (mention specific platforms if applicable).

Knowledge of supply chain management principles.

Certification in relevant areas (e.g., quality management, project management).