Your responsibilities:
1. Validation activities: Facilities, Utilities, Validation Life Cycle.
2. Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
3. The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
4. Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems, and utilities.
5. Write reports of completed validation activities.
6. Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA.
7. Writing and/or revising procedures applicable to the Engineering activities.
8. Support the Engineering group to prepare the validation, requalification, and maintenance program.
Your background:
1. Bachelor in Science or Technical field.
2. Advanced Level Pharma Industry 5-10 years.
3. Excellent technical writing skills and the ability to document all work in a thorough, accurate, and timely manner.
4. Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
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