QC Senior Analyst

To ensure the quality of items tested at QC through performing analysis of
procured items and manufactured products by 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 product in a
manner to meet all AstraZeneca standards.
Compliance & Governance:
It's the ultimate responsibility of the job holder to comply-with and follow
all applicable AstraZeneca policies (e.g. SHE, GMP, FCF, ABAC, EI, etc) along
with the Egyptian local laws and regulations relevant to the job
responsibilities and exposure.
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

Sampling activities
* Ability to withdraw water, bulk and raw materials samples.
Reagents preparation
* Preparation of chemical reagents and other required volumetric solutions.
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
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
Lab equipment
* 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.
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.
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.
* Managing the consumables budget and budget phasing.
* Monthly check to remove any expired consumable.
* Ensure all the consumable are stored in their relevant recommended storage conditions.
Specific responsibilities
* 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 Technical support and training to QC staff.
Education, Qualifications, Skills and Experience:
* B.SC in Pharmaceutical science.
* ‎5 years of expereince in pharmaceutical inducstry
* Good command of English
* Basic computer skills
* Ability to learn
* Problem solving
* Possess good awareness for basic GMP requirements
* Laboratories technical and Analytical background
* Good analytical skills
* Time management
* Communication skills
* Certified Lean six sigma is preferred