Validation Specialist
The role of the validation specialist is to ensure customer satisfaction by validating equipment, systems, and processes in a pharmaceutical company. The specialist will work closely with senior management and other departments to prioritize and manage projects effectively.
Responsibilities:
* Oversee and coordinate validation activities for new equipment, processes, or changes to existing ones.
* Develop and implement validation plans, protocols, and reports in line with regulatory requirements.
* Work with engineers to ensure that all validation requirements are met.
* Participate in risk assessment and design review processes.
* Track and generate weekly metrics on quality management, environment, health, and safety compliance.
* Facilitate PQR reviews and laboratory equipment reviews.
* Stay up-to-date with changing regulatory guidance and provide support for audit preparation, direct audit interaction, and audit response.
Requirements:
* Bachelor's degree in a science-based or engineering discipline.
* Experience in the pharmaceutical industry.
* Excellent project management skills.
* Proficiency in Microsoft Office suite.
* Critical thinking and problem-solving skills.
* Ability to articulate clearly.
* Conflict handling skills.
* Expertise in relevant subject matter areas, such as equipment, facilities, aseptics, process control, cleaning validation.