Job Title
Validation Specialist
About the Role:
The quality control pharmaceutical department is responsible for qualifying and validating laboratory equipment, systems, and processes used in routine operations at laboratories.
The role of the validation specialist is to ensure customer satisfaction by delivering high-quality revalidations, validations, and project work.
Validation activities must be performed in accordance with global standards, FDA regulations, HPRA requirements, and other regulatory guidelines.
Key Responsibilities:
* Oversee, coordinate, guide, and implement site validation masters for prospective, concurrent, and retrospective validation studies on time with relevant engineers.
* Ensure that all validation requirements are met for new processes, equipment, or changes to existing processes or equipment.
* Work actively on validation projects as the departmental point person and complete associated project documentation in line with current corporate and regulatory expectations.
* Compile, authorize, and file validation study documents in a timely and organized manner.
* Collaborate with other validation engineers to achieve compliance by coordinating each assigned validation project.
Requirements:
* Bachelor's degree required in science-based or engineering discipline.
* Experience in the pharmaceutical industry.
* Excellent project management skills.
* Proficient in Microsoft Office suite of programs.
* Critical thinking and problem-solving skills.
* Ability to articulate clearly when communicating with internal and external stakeholders.
* Excellent conflict resolution skills.