CSV Project Manager

3 days ago

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Azzur Group

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regulatory compliance • commissioning • qualification • maintenance • calibration and validation

201 - 500

💰 Venture Round on 2021-04

Description

• We are seeking an experienced CSV Project Manager to lead and manage critical computer system validation (CSV) projects. • Ensuring all activities are conducted in compliance with regulatory requirements and quality standards. • Responsible for coordinating efforts across various teams, managing stakeholders, maintaining project plans, and ensuring timely execution of validation activities. • Requires a deep understanding of a QA system, and the ability to effectively resolve conflicts and facilitate communication. • Drive projects to completion.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field. • Minimum of 5 years of experience in CSV or related project management roles, with a focus on regulated environments (pharmaceutical, biotechnology, etc.). • Proven experience in managing cross-functional teams and negotiating with stakeholders to resolve conflicts and achieve project goals. • Exceptional communication skills, with the ability to convey technical information to non-technical stakeholders and facilitate consensus. • Strong problem-solving skills and attention to detail. • Ability to work independently, manage multiple priorities, and adapt to changing project needs. • Certification in Project Management • Experience with validation documentation, such as test scripts, validation protocols, and validation summary reports. • Familiarity with regulatory standards such as FDA 21 CFR Part 11, EU GMP, or other relevant industry guidelines.