- Responsible for Preparing Quality reports, including analytical reports (Stability).
- Follow Up Stability Chambers (Accelerated, Long Term and Shelf) and its Calibration, IQ, OQ and maintenance. Responsible of samples in & Out of the Chambers According to monthly and weekly plan.
- Preparing Monthly plan and Weekly plan of stability and Methodology products as (Accelerated, Long Term, Shelf, In-Use, Validation and Comparative dissolution) and distribution the products on the team of analysis.
- Make Supervision on the Laboratory, all Members, instrument’s logbooks and Analyst’s logbooks
- Follow Up all daily activities concerning to stability lab.
- Preparing Standard Operating Procedures (SOP) for all new instruments.
- Review preparing Traceability on the finished Stability studies that send to stability committee.
- Responsible for Ensuring that procedures are carried out carefully and accurately to eliminate errors.
- Working with all members of staff to maintain and develop the positive progressive culture within the Specials Laboratory.
- Observing and complying with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
- Conduct training to fresh analyst.
- Observing and complying with company Standard Operating Procedures (SOPs).
- Responsible for execution and review of stability protocols for RD and pilot samples
- Responsible for preparation of stability files for submission for regulatory aspects
- Responsible for preparation of CTD files for submission for regulatory aspects
- Responsible for preparation of Export files for submission for regulatory aspects.
- Contribute with other departments (QC, QA & RA).
Bachelor of pharmacy & Science6-8 years of experience (at least one year experience as stability supervisor).Excellent verbal, written and interpersonal communication skills.English fluency is essentialProfessional computer and MS-Office skillsProfessional analytical skillsStrong organizational and multitasking skillsAttention to details