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 Quality control analyst At GSK



Quality control analyst At GSK


Giza, Egypt
Quality

Site Name: Egypt - Giza

Job Purpose

Ensure working in a safe environment. Test and analyze lab samples, and operate lab equipment and instruments, to ensure the quality of products and materials in compliance with GSK standard, specification, local requirements and GMP. Working with our values and expectations in mind.

Key Responsibilities:

Physical examination of the product before analysis.
Analysis of pre-market, trials, validity extension & routine stability samples.
Analyze and test Raw and Packaging materials, RM re-testing and intermediates as well as finished products according to approved protocols and specifications.
Handling of supplier complains.
Ensure that the data integrity requirements are fulfilled during work.
Operate & Calibrate departmental section equipment and instruments according to approved SOP's e.g. HPLC, GC, UV/Vis, IR and Atomic Absorption Spectrophotometer, balances and other analytical equipment.
Implement and maintain GMP, GLP relevant to his/ her job.
Handling of stability chambers & incubators & follow up their maintenance.
Perform analytical method validation & verification for all products.
Perform Qualification for new products & active ingredients.
Analytical method development for different drug products & drug substances.
Prepare the Q.C. data according to MOH 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.
Technical Support for the other quality control sections.
Perform Cleaning Validation for production machines according to cleaning validation plan.
Prepare, standardize and maintain availability of reference standard, volumetric solutions, glassware, and reagents and ensure their good handling and storage according to the approved SOP's.
Ensure that EHS requirements are fulfilled during work.
Out of Specification handling: Contribution in investigation using root cause analysis.
CAPA management: Set corrective actions and preventives action plans for L1 audit points and required action for improvement and follow up for progress.
Change control system: Contribution in implementation of change control system for any process or equipment.
Applying the GSK production system “GPS” basic elements in the analytical lab to reach zero accident, zero waste & zero defect.
Additional non-routine tasks related to section or individual’s development plan may be assigned.
Knowledge/ Education / Previous Experience Required:

Education and Experience:

Bachelor’s Degree- Pharmaceutical sciences
2-3 year of experience
Essential Skills and Abilities:

Energy and Resilience
Communication Skills
English Language
Computer Skills

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