1- Sampling
- Ability to withdraw water, bulk and raw materials samples.
2- Reagent preparation
- Preparation of chemical reagents and other required volumetric solutions.
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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.
5-Instrument
- 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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