QC analyst At GSK | Pharmacy Vacancy | 1 to 3 years of experience
Job description
Site Name: Egypt - Giza - Giza
Posted Date: Mar 18 2021
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. 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.
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 / Experience Required:
University Bachelor's degree from faculty of Pharmacy or equivalent.
1 to 3 years of experience in the pharmaceutical industry.
Experience in QC, methodology and Method validation is preferred.
Good Knowledge of GLP, EHS and GMP requirements.
Displays Energy and Resilience.
Good command of the English language.
Good Computer Skills.
Excellent communication and interpersonal skills.
Actively seek to improve processes, controls and expand effectiveness and efficiency.
Self-motivated with Good prioritization and organization skills.
Ability to work independently and as part of a team.