, pub-2091334367487754, DIRECT, f08c47fec0942fa0 QC Senior Analyst At AstraZeneca Egypt

QC Senior Analyst At AstraZeneca Egypt

 QC Senior Analyst At AstraZeneca Egypt

QC Analyst At AstraZeneca

Location:6th of October City

Full Job Description

1- Sampling

Ability to withdraw water, bulk and raw materials samples.
2- Reagent preparation

Preparation of chemical reagents and other required volumetric solutions.
3- Analysis

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.
4- Documentation

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.

8- SHE

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)

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