Cleaning Validation Specialist

7 days ago

Greater Toronto Area, Canada Kelly Science, Engineering, Technology & Telecom Full time

Job Summary:

As a Cleaning Validation Specialist, you will play a crucial role in leveraging your specialized expertise to ensure the cleanliness and safety of our manufacturing and packaging processes. Your primary responsibility will be to execute protocols and generate reports, ensuring strict adherence to Standard Operating Procedures (SOPs), client specifications, and Good Manufacturing Practices. Your proficiency and guidance will significantly contribute to the efficiency of our operations and overall client satisfaction.


Roles and Responsibilities:

- Provide leadership and support - offering problem-solving, training/mentoring, and advancing project development.

- Develop and implement validation protocols for new and existing clients, as well as author thorough reports.

- Review team documents and serve as the designated validation manager.

- Provide direction to junior team members on validation requirements and strategies through group sessions and individual interactions.

- Review and endorse assessments, deviations, change controls, protocols/reports, and the Master Validation Plan.

- Verify and analyze data, conduct statistical assessments, and coordinate validation tasks in alignment with production schedules.

- Spearhead the cleaning validation initiative, ensuring alignment with industry norms.

- Support necessary equipment swabbing activities.

- Represent as the validation lead in client meetings when needed.

- Update assigned Master Validation Plans (MVPs) in line with validation protocols.

- Offer assistance in audits and regulatory compliance.

- Lead and guide technical inquiries and oversee the execution of Corrective Action Preventative Action (CAPA) plans.


Qualifications & Skills:

- Education: Bachelor of Science degree in Chemistry, Engineering, or a related field.

- Experience: Minimum of 5 years of validation practice in the pharmaceutical sector.

- Previous exposure to project management and statistical evaluation is advantageous.

- A blend of education, training, and relevant work background may be considered.

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