- 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