Project Validation Specialist

Job Description:

Project Validation Specialist Job Description:

The Project Validation Specialist is responsible for managing both internal and external projects, as well as writing and executing validation packages. These packages can include documentation related to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Computer System Validation (CSV). The role demands strong project management skills, attention to detail, and a deep understanding of qualification processes to ensure compliance and product performance.

Key Responsibilities

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.

Qualifications:

• Education: Bachelor’s degree in Engineering, Sciences, or a related field. Certification in Project Management (e.g., PMP) is a plus.
• Experience: Minimum of 3-5 years of experience in project management and qualification activities in regulated environments (e.g., pharmaceutical, medical device, or biotechnology sectors).

Skills:

• Strong knowledge of validation/ qualification processes.
• Experience in developing, executing, and reviewing qualification documentation.
• Excellent project management, organizational, and communication skills.
• Proficiency in using project management tools.
• Ability to work under pressure and meet tight deadlines.

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