Senior QC Analyst At Hikma Pharmaceuticals
Ensuring the quality of items tested at QC through performing analysis of procured items and Raw Materials supplied to the plant. In addition to performing lab testing as required for investigational and other business reasons. Carry out all relevant activities that ensure the release of the product in a manner to meet all Hikma Compliance & Governance:
Responsible for the proper implementation of 5S in the lab.
Properly disposing of 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 Sampling activities Ability to withdraw water, bulk and raw materials samples.
Reagents preparation of chemical reagents and other required volumetric solutions.
Analysis Performing chemical and physical analysis of water samples, raw materials, and imported and manufactured bulk products according to the approved standard official methods.
Checking the imported raw materials 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 TSs, SOPs, instructions, and records in compliance with Hikma’s standards.
Managing changes according to the predetermined procedures.
Preparation of validation protocols and worksheets Lab equipment Responsible for following up the preventive and corrective maintenance, cleaning and labelling of all QC lab equipment.
Responsible for following up on the calibration plan and ensuring that all the calibrations were done before the due dates.
Ordering the required consumables on time to avoid running out of stock.
Monthly check to remove any expired consumable.
Ensure all the consumables are stored in their relevant recommended storage conditions.
Specific responsibilities Lead the QC PDCA.
Support in achieving the analysis lead times.
Provide Technical support to QC analysts
B.SC in Pharmaceutical Science or Science.
3-5 years of experience in the pharmaceutical industry, preferred in raw material analysis.
Possess good awareness of basic GMP requirements
Laboratories technical and Analytical background
Good analytical skills