Validation/Qualification of utilities (i.e. WFI, UPW, Process air), processing equipment, testing equipment, facilities. Work with equipment owners/users, Quality personnel to qualify and requalify various equipment
Ensure that assigned validation activities are performed timely and in line with the current *** requirements and cGMP,
handling any deviations associated with these activities.
Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalifications,
Perform process qualification for new equipment and new technologies.
Perform risk assessments for Validation.
Operating Procedures (SOPs).
Training: Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions.
Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
Previous validation/qualification experience