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
More than 5 years
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.