Job Description:
The Quality Assurance Department is responsible for the qualification/validation of laboratory equipment, systems, and processes used in routine operations.
The role of the Validation Engineer is to ensure customer satisfaction through each revalidation, validation, and project work. All validation activities must comply with Global Standards, FDA, HPRA, and other regulatory requirements.
This involves overseeing and coordinating site validation master studies, ensuring all validation requirements are met.
Work on validation projects as the departmental point person, completing associated documentation according to corporate and regulatory expectations.
Participate in risk assessments and design reviews for all business units.
Track and generate weekly metrics (QMS, EHS, Compliance).
Facilitate PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process.
Stay up-to-date with changing regulatory guidance and provide support for audit preparation, direct audit interaction, and involvement in audit response.
Ensure compliance with internal EHS requirements, procedures, and policies, achieving quality objectives through continuous improvement efforts. -----------------------------------