QA Supervisor/ Section Head (Validation)

Main Duties:

• Responsible for compliance to cGMP within the different activities in Pharmed Healthcare.
• Arranging and co-ordination for the validation through issuing and follow up for validation master plan.
• Preparing the required documentation including SOPs, protocols and report for validation and qualification.
• Qualification of all production machines, lab instruments and engineering utilities including URS issuance, IQ & OQ & PQ, till final closure to the qualification report.
• Initiate and update the layout for the facilities and utilities.
• Reviewing and archiving the trend analysis for the water system and HVAC system performance.
• Arranging, execution and follow up for manufacturing process validation, cleaning validation and analytical methods validation.
• Assessing the dirty and cleaned equipment holding time.
• Identifying the hold time study for the products during different manufacturing stages.
• Qualification for the HVAC, water system, utilities, software (that impact the product quality), storage, sterilization and miscellaneous items which require validation.
• Preparation and reviewing the stability protocol and collected analysis data for ensuring the shelf life for the products.
• Coding of rooms, equipment, HVAC system, water system and utilities related items and used point including.
  Scheduling the calibration for the machines and equipment.
• Qualification of the vendors and including revision for the tests to be reduced in co-operation with the QC lab.
• Issuing and updating the risk analysis for any subjects concerning the qualification and validation activities.
• Responsible to execute any responsibility as and when assigned by Head- QA.