Project Manager CQV
Vor 2 Tagen
Job description:
- The scope of activities includes the coordination on the installation of equipment, HVAC & Utilities (20%)
- Drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according to cGMP requirements.
- Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
- Prepare validation documents.
- Execution of IQ/OQ and PQ for equipment, systems and utilities.
- Write reports of completed validation activities. Work to identify efficiencies in the validation program approach.
- Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment/facility validation.
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
- Writing and/or revising procedures applicable to the Engineering activities.
- Support the Engineering group to prepare the validation, requalification, and maintenance program.
Your profile:
- Bachelor’s degree in science or technical field.
- Language: English.
- Advanced Level Pharma Industry 5-10 years.
- Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
- Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
- Excellent organizational and time management skills.
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