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Job Description
- 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.