Stability Supervisor - Quality Control

Full Time

On-site

Zeta Pharma -
Alsadat City, MonufyaPosted 10 months ago

26Applicants for1 open position

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Job Description

Responsible for Preparing Quality reports, including analytical reports (Stability).
Follow Up Stability Chambers (Accelerated, Long Term and Shelf) and its Calibration, IQ, OQ and maintenance. Responsible of samples in & Out of the Chambers According to monthly and weekly plan.
Preparing Monthly plan and Weekly plan of stability and Methodology products as (Accelerated, Long Term, Shelf, In-Use, Validation and Comparative dissolution) and distribution the products on the team of analysis.
Make Supervision on the Laboratory, all Members, instrument’s logbooks and Analyst’s logbooks
Follow Up all daily activities concerning to stability lab.
Preparing Standard Operating Procedures (SOP) for all new instruments.
Review preparing Traceability on the finished Stability studies that send to stability committee.
Responsible for Ensuring that procedures are carried out carefully and accurately to eliminate errors.
Working with all members of staff to maintain and develop the positive progressive culture within the Specials Laboratory.
Observing and complying with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
Conduct training to fresh analyst.
Observing and complying with company Standard Operating Procedures (SOPs).
Responsible for execution and review of stability protocols for RD and pilot samples
Responsible for preparation of stability files for submission for regulatory aspects
Responsible for preparation of CTD files for submission for regulatory aspects
Responsible for preparation of Export files for submission for regulatory aspects.
Contribute with other departments (QC, QA & RA).