Quality Supervisor 10th OF Ramadan

Confidential Company - 10th Of Ramadan City, Cairo

48
Applicants for
1 open position
48
Viewed
1
In Consideration
46
Not Selected
Experience Needed:
More than 5 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential, Incentive
Languages:
English, Arabic
Vacancies:
1 open position
About the Job
  • Manages the calibration of critical equipment all over the plant as well as keeping records of calibration certificate of all physicochemical instruments
  • Participates in new projects planning by setting GMP & MOH requirements.
  • Conduct product quality reviews & assist in developing further studies regarding the introduction of new product/products versions in the production cycle as well as their production launching plan, requirements & timeframes 
  • Manage plant validation activities like process validation , cleaning validation & analytical method validations
  • Research & development of the process & when appropriate, intermediate & products according to pre-approval instructions
  • Approves the system of sampling, release or reject, in process materials intermediate, raw materials, packing labeling materials & finished goods,
  • Approve sampling & product quality control using SPC (statistical process control) and carry out investigation for critical deviations & making sure that all Non-conformities are reported , evaluated , resolved & conclusions are recorded:
  • Approve statistical analysis regarding the stability data to support retest or expiry dates and storage conditions on products and/or raw materials.
  • Manages his/her subordinate's time to get max. benefit & efficiency of them
  • Approve all quality control standard operating procedures to ensure that they are complying with the official references and that they are clear unambiguous and easily followed
  • Ensure that all chemical & bacterial analysis of water, I.P.C & FP analysis, all raw materials & packaging materials are done according the plant standard operating procedures
  • Ensures that preparation of all test and volumetric solutions is done correctly & following GLP
  • Participate in the suppliers evaluation as well as sampling from their own facilities for compliance checking
  • Provide support in investigating quality complaints & quality inconsistencies
  • Evaluate the performance  of his/her team
  • Follow all EHS lab instructions
Job Requirements
  • At least 5 years experience in the MEDICAL devices field ONLY 
  • Experience in both QC & QA is a must
  • Has the ISO 9001 & 13485:2016 MDR training certificates.
  • V. Good knowledge by the MOH requirements.
  • V. Good knowledge by the ISO & CE certificates requirements.
  • V. Good knowledge by the new products required steps till the product launch in the market.
  • Good network for the analytical labs and studies offices.
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