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QC/Stability Analyst At GSK - vacanciesblog 2024

QC/Stability Analyst At GSK

QC/Stability Analyst At GSK

QC/Stability Analyst At GSK
QC/Stability Analyst At GSK

Quality Control Stability and Technical Service Analyst At GSK Egypt

Location: Giza, Egypt

Job Purpose:

Ensure working in a safe environment. And analyzing with compliance to quality standards. Routine analysis of products to provide evidence on how the quality of medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity and to establish a shelf life for the medicinal product and recommended storage conditions. Review the results against specification, local requirements and GMP Working with our values and expectations in mind.

Key Responsibilities:

Analysis of pre-market, trials, validity extension & routine stability samples.
Handling of stability chambers & incubators & follow up their maintenance.
Perform analytical method validation & verification for all products.
Prepare the Q.C. data according to EDA requirements to coordinate with regulatory affairs division.
Responsible for keeping the retained samples of materials and products and their disposal, according to the approved SOP’s.
Perform Cleaning Validation for production machines according to cleaning validation plan.
Out of Specification handling: Contribution in investigation using root cause analysis.
Providing the necessary Technical support to interpret, decide and evaluate any problem related to technical Service section & its corrective/preventive actions
Ensure Stability Testing is on time with the required Quality
Additional non-routine tasks related to section or individual’s development plan may be assigned.
Reviewing the results and COAs for routine stability analysis, Cleanning validation, and analytical method validation reports and protocols.
Ensure the implementation of up to date SOP’s in line with changes to the source documents, such as GQP’s, GQG’s, FPG’s or regulatory documents and assess the related performance via periodic trend evaluation & annual product review. In addition, to ensure that EHS Policies and Procedures are implemented in the Finished products section.

Knowledge/ Education Required:
Bachelor’s Degree required in Pharmaceutical Sciences.
Minimum 3 years of job related experience required.
Closing Date: 21/06/2023

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