Skills And Tools:
- Create Analytical method validation/verification protocols & review results.
- Create RRF calculation study protocol & review results.
- Create Cleaning Method, and performing its validation protocols to estimate LOD & LOQ.
- Creating extraction methods for OEL.
- Analytical method development for new products.
- Writing & updating SOPs & testing standards.
- Create & update Excel calculation sheets.
- Responsible for EDA letters.
- Prepare Quality modules requirements.
- Reply Checklists of Quality modules.
- Preparation of NODCAR files.
- Create inspection plans on SAP.
- Train & support the AR team.
- Preparation and review of Specifications, Method of analysis procedures and Analytical development reports of Tec transfer.
- Work with QC SV as back up
- 5- 8 year of successful laboratory experience (Sterile Area).
- B.Sc. degree in Pharmacy or Science.
- Preferably (Cairo, Obour, New Cairo, Nasr City, Heliopolis, Badr, Zagazig, Sharqiyah, and 10th of Ramadan) residents.
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