Quality Assurance Specialist

3 months ago

Cairo, Egypt Amoun Pharmaceutical Full time
Job Description
  • Oversees and provides guidance to the implementation of G M P principles in ware house & production departments
  • Monitor the process of dispensing of raw materials by checking the cleaning of the weighing booth, cleaning of the balances & their calibration
  • Verifying the correctness of the dispensed materials against the issued production order & recording the weights in the dispensing sheet in B.M.R. & checking the calculation of potency of active materials & the labels of dispensed materials
  • Monitor the environmental conditions in the main store as well as dispensing rooms
  • Monitor all manufacturing steps and ensures review of the manufacturing check lists.
  • Monitor the set up of the machines , the environmental conditions , line clearance & cleaning of the rooms & equipment
  • Monitor all packaging steps and ensures review of the packging check lists.
  • Reviews the Batch Records and its related documents against the Batch Review and Release forms.
  • Share in the Internal Quality Audit programme as an auditor
  • Manages deviations & incidents (Non conforming events)
  • Prepare the data from the batch record for Annual product review
  • Accompany MOH inspector during sampling of the raw materials & finished product & Send the samples taken by MOH inspector to NODCAR to be analyzed
  • Manage the change control request
  • Responsible for collecting all related documents for Annual product review to present them in the final shape
  • Introduce the manufacture date & expiry date to the finished product
  • Changes the data in Batch record acc. To the request from R&D or production

Performs any other related duties as and when required

Job Requirements

Education:

Bachelor Degree of pharmacy

Past Experience:

Minimum experience of 1 year in quality assurance in pharmaceutical companies

Special Competencies:

  • High level analytical skills.
  • Good written and spoken English Language.

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