Description
Job description
General Responsibility:
Support to the responsible of Laboratory Equipment Calibrations
Ensure the compliance of validations, qualifications and calibrations of the equipment used in the analysis of pharmaceutical products.
Active participation in the maintenance and continuous improvement of the calibration / qualifications management system.
Specific Responsibilities:
- Perform qualification protocols (IQ, OQ, PQ) for Laboratory Equipment and / or review those provided by the external companies responsible for carrying out the qualifications.
- Carry out qualification reports of the Laboratory Equipment after the execution of these and / or review those issued by the external companies that have executed the qualifications.
- Organize and keep updated the calibration documentation.
- Elaborate the preventive and corrective calibration plans of the laboratory equipment.
- Collaborate in conducting tests and compliance procedures with 21 CFR for Audit Trail verification of the analysis (data integrity) in the laboratory equipment.
- Collaborate in the preparation of procedures for the use of laboratory equipment
Requirements: