Roles and Responsibilities
• 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).