QA Qualification Professional officer at Sanofi – One Year Contract (Energy Project)

JOB PURPOSE:

Controlling, executing, and improving Calibration and Qualification Activities for all critical instruments, equipment, HVAC system and other supporting systems in the site.

Main Responsibilities:

Create Calibration Management Program according to Sanofi Guidelines and Directives.
Perform risk assessment studies for all items or instruments in the plant to define items subjected to calibration.
Create Calibration Plan and Qualification Plan.
Calibration of all critical instruments in the site using standard calibrated devices according to calibration management program, sticking to the approved annual plan and SOPs.
Issuance of Calibration Certificates for calibrated items.
Creation of IQ, OQ and PQ Protocols for Equipment and Systems in the site and Execute Qualification studies for equipment (Production Machines, Autoclaves, Tunnels, Ovens, Incubators, Refrigerators and Cold Stores… etc.) and HVAC system according to the approved qualification plan and protocols.
Establishment of a database for all equipment and machines in the site to evaluate capacity and support CAPEX need in co-operation with maintenance Dept.
Arrangement and Support Calibration activities performed by third party contractors when needed.
Supervise Activities executed by contractors and review final reports generated by them.
Act as Investigation leader for deviation relevant to calibration and qualification.

HSE Responsibilities:

Ensures HSE approval on any SOP that requires certain HSE precautions.
Ensures HSE approval on any change.
Follow the laboratory safety procedures
Commitment to the appropriate PPE use.
Follow the approved HSE policy and requirements.
Following the statutory legislation concerning Health, Safety and environmental law.
Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

Key “MUST HAVE” competencies, skills & experiences: