The scope of activities includes the coordination on the installation of equipment, drafting the IQ / OQ / PQ protocols, execution of the IQ / OQ / PQ and documenting the results according cGMP requirements.
Responsibilities :
* 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.
* Perform other duties as assigned.
Requirements :
* Bachelor’s Degree in Science or Technical field
* 3-5 years of experience in pharma Industry
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