Project Validation Specialist

Project Management:

• Lead and manage internal and external projects from initiation to completion.
• Define project scope, goals, deliverables, and timelines.
• Collaborate with cross-functional teams to ensure project objectives are met on time.
• Monitor and report on project progress, risks, and issues, proposing solutions where necessary.
• Coordinate with stakeholders, including clients, vendors, and internal personnel.

Validation/ Qualification Documentation:

• Develop and write qualification packages, including IQ, OQ, PQ, and CSV documents.
• Ensure compliance with relevant regulatory requirements (e.g., FDA, GMP, etc.).
• Plan and execute qualification protocols and testing for equipment, systems, and processes.
• Prepare reports and documentation to verify that equipment and systems meet specified standards and operate within intended parameters.
• Ensure qualification packages are completed accurately, and maintain proper records for audits and inspections.

Team Collaboration:

• Work closely with Engineering, Quality Assurance team, and other departments to gather necessary data for qualifications.
• Provide guidance and mentorship to team members involved in qualification activities.
• Maintain communication with project teams to ensure smooth execution of both qualification activities and project timelines.

Continuous Improvement:

• Identify areas for improvement in qualification processes and project management methods.
• Ensure ongoing compliance with industry standards and best practices.
• Stay updated on industry trends and changes in regulatory requirements affecting qualification activities.