Quality Control Supervisor At AstraZeneca Egypt
Job Description and requirements:
QC authorized person Accountable for Products/Materials analysis revision / disposition
- 7-9 years of experience
- 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 including micro review activities.
- Support in achieving the analysis lead times.
- Provide support and training to QC staff.
- Hold the initial and extended Lab investigation with the QC analyst in case of OOS/OOT
Management of lab equipment
- Responsible for purchasing, qualification and calibration of new lab equipment (PQ, OQ and IQ)
- Responsible for periodic equipment calibration and qualification
- Follow up with agents on preventative maintenance
Instruments
- Responsible for following up the preventive and corrective maintenance, cleaning and labelling of all QC lab equipment.
- Responsible for following up the calibration plan and ensuring that all the calibrations were done before the due dates.
- Support the QC team members in troubleshooting of minor issues related to equipment and provide the proper training for equipment usage.
QC stock management
- Preparing the QC consumables (OPEX) budget and budget phasing.
- 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.
Analysis
- Performing chemical and physical analysis of water samples, raw materials, imported and manufactured bulk products according to the approved standard official methods.
- Performing micro activities as required (microbial analysis of water, EM, microbial analysis of raw materials and manufactured bulk) and after completing needed qualifications.
- Checking the imported bulk received at the warehouse.
- Reporting any deviations, OOS/ OOT results
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
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
Audit observation
- Own and close audit observations against different areas in the Lab.
Closing Date
06-Jul-2024