نوع العمل : عمل كلى
الخبرة : 9-10 سنة
الراتب : N/A
المكان : Egypt
الخبرة : 9-10 سنة
الراتب : N/A
المكان : Egypt
Job Details
Experience Needed:More Than 7 Years
Career Level:Manager
Education Level:Bachelor's Degree
Salary:Confidential
Job Categories:
Skills And Tools:
Job Description
- Review SOP concerns about raw material and packaging.
- Check the Instruments/Equipment Logbook, Results of Analysis, COA & SOPs.
- Check sampling and receiving of raw material samples for analysis.
- Maintain the implementation of GLP rules inside the laboratory.
- Review raw & packaging material test methods.
- Follow up on the implementation of the raw material retest plan.
- Follow up on the implementation of the raw material standardization plan and process.
- Ordering of required reference standards (Primary, CRM) based on the needs of other QC lab departments and the necessity of regulatory requirements.
- Review results, raw data, and COA of raw material.
- Chemical and physical analysis review according to the test method and specification.
- Review of intermediate check of instrument concern, raw material, and packaging lab.
- Reporting deviation, suspect results, out-of-specification results, and any other required.
- Supervision of training needs, plans, and records for raw material and packaging reports.
Job Requirements
- Bachelor’s degree in Pharmacy or Sciences.
- +7 years in a reputable pharmaceutical company with substantial expertise in raw material & packaging quality control.
- In-depth knowledge of SOP control, QMS processes, batch release systems, and documentation management for SPCs, STPs, and worksheets.
- Hands-on experience with operating and calibrating advanced laboratory instruments, including HPLC and GC.
- Strong leadership and people management skills, with the ability to set goals and organize resources efficiently.