Duties:

• 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 Client 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.

Skills: Previous validation/qualification experience