Back to jobsEquipment, Facilities, and Utilities Qualification: Manage the validation lifecycle using the V-Model approach, from User Requirement Specification (URS) to technical evaluation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) Initial qualification (IQ, OQ & PQ), Requalification. Ensuring the Utilities (Purified Water, Water for injection, Compressed gases & Nitrogen Gases) in the Qualified state. Ensure the clean room Qualifications shall meets the ISO-14644 requirements.
Calibration activities: has full understanding about calibration activities (rational, setting criteria and frequencies, outsourcing calibrations.
Computerized System Validation (CSV): Ensure compliance and validation of Quality control, manufacturing and utilities-related software. Ensure that any new critical systems shall meet the 21 CFR part 11 requirements.
Team Management: Assign tasks to Validation SMEs for qualification and validation activities.
Quality & Compliance (EQMS): Handle Change Control, Deviation Investigations, CAPA, and Audit Management, providing technical expertise on validation and qualification.
Cross-Functional Coordination: