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

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