Seeking a skilled professional to lead pharmaceutical facility operations as a Validation Specialist. This role involves close collaboration with various functions to develop and execute a compliant validation strategy.
Responsibilities:
* Guide validation activities, ensuring timely execution and compliance with industry regulations.
* Develop, review, approve and execute commissioning, installation and qualification protocols for solution preparation equipment.
* Manage and coordinate solution prep equipment commissioning and qualification activities, leveraging expertise in GxP systems.
The ideal candidate will possess a strong background in qualifying GxP systems, prior experience as a senior validation specialist, and knowledge of EU and other global regulatory requirements.
Requirements:
* Proven track record of successful validation project management.
* Excellent communication and collaboration skills.
* Strong understanding of pharmaceutical manufacturing processes and regulatory frameworks.