القائمة الرئيسية

الصفحات

QA Validation Senior Officer At Sanofi

QA Validation Senior Officer At Sanofi

QA Validation Senior Officer At Sanofi


Job Purpose:

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

Tasks and Responsibilities:

1- Perform different qualification activities (HVAC, Temperature mapping & thermal mapping)

Issuance of annual/half-annual qualification plan.
Initiate qualification packages (DQ, IQ, OQ and PQ) protocols.
Execute routine qualification activities following the approved protocols and annual plan (Autoclaves, Tunnels, temperature mapping, HVAC.)
Monitor third-party agents performing qualification activities.
Perform summary report for activities performed by third party.
Manage qualification activities for projects (Area revamping, machines transfer, new machines).

2-Perform different calibration activities (Temperature, Pressure, RH, etc..)

Perform in house calibration activities as per defined SOPs and annual calibration plan.
Record and issue different types of calibration certificates.
Monitor third-party agents performing calibration activities.
Perform summary report for activities performed by third party.

3- Management of Qualification and Calibration plans.

Issuance of annual calibration and qualification plans.
Issuance of periodic plans assessment.
Initiate different types of qualification protocols & calibration SOPs.
Management of deviations related to calibration and qualification activities.
4-Perform different validation activities (Process, cleaning & packaging)

Issuance of annual VMP.
Initiate different types of validation protocols
Monitor the execution of validation activities
Perform validation data analysis.
Reporting of final different validation results
Key “MUST HAVE” competencies, skills & experiences

Experience in direct execution of calibration, qualification and validation activities (4 to 7 years).
Problem solving and Decision making capabilities.
Good command of MS office applications and data analysis systems.
Good knowledge of GMP regulations.
Excellent command of English Language.
TQM or equivalent is a plus.

Apply Here

reaction:

تعليقات