QC Senior Analyst At AstraZeneca Egypt
Location:6th of October City
Full Job Description
Ability to withdraw water, bulk and raw materials samples.
2- Reagent preparation
Preparation of chemical reagents and other required volumetric solutions.
Performing chemical and physical analysis of water samples, raw materials, imported and manufactured bulk products according to the approved standard official methods.
Checking the imported bulk received at the warehouse.
Reporting any deviations, OOS/ OOT results.
Documentation, recording and reporting of analytical results according to the predetermined instructions.
Reporting and documenting any incidents, out of specifications and out of trend results according to the predetermined procedures.
Prepare the SOMs, SOPs, instructions and records in compliance to AstraZeneca’s standard.
Managing changes according to the predetermined procedures.
Preparation of validation protocols and worksheets.
Responsible for the proper maintenance, cleaning and labelling of different lab equipment.
Responsible for following up the calibration plan and ensuring that all the calibrations were done before the due dates.
6- Stability management
Responsible for doing a stability master plan at the beginning of each year.
Responsible for supplying the commercial stability site with required quantities of stability samples as requested.
Responsible to manage the launch of a new product.
Responsible for checking the stability study results and reporting any deviations, OOS/ OOT results.
7- QC stock management
Follow up of the available stock every month or quarterly whatever appropriate based on consumption rates.
Ordering the required consumables on time to avoid. running out of stock.
Monthly check to remove any expired consumable.
Ensure all the consumable are stored in their relevant recommended storage conditions.
Responsible for the proper implementation of 5S in the lab.
Properly disposing all contaminants and different hazardous and bio-hazardous materials.
Acquiring and following all the consumables MSDS.
Adhere to the site’s SHE policies and requirements.
9- Audit observation
Own and close audit observations against different areas in the Lab.
10- QC Authorized Person specific responsibilities
Management, utilization and upgrade of the different Lab resources. (Man power, Equipment and consumables).
Lead the QC PDCA.
Act as the QP for release of Procured and manufactured products within the QC.
Support in achieving the analysis lead times.
Provide support and training to QC staff.
Years of experience 3-5 years
Fixed contract for 2 years (contingent worker for project purpose)