Stability Manager

2 weeks ago

مصر, Egypt Jamjoom Pharma Full time

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

**About the job**:

- Supervise quality control laboratory work to ensure Shelf-Life quality of solid, semisolid, liquid sterile and non-sterile finished products as well as their packaging materials to be in compliance with cGMP, Regulatory guidelines and Business requirements. Lead stability team to fulfill Regulatory (registration and submission) Stability requests and ensure full compliance to EDA stability guidelines in stability team practice at Jamjoom Pharma - Egypt.

**Responsibilities**:

- Supervise and maintain GLP, GMP, and safety regulations in Stability Department and ensure good handling and proper operation of laboratory equipment and instruments.
- Review and approve stability protocols for new trial batches, validation batches and production batches.
- Prepare and Revise SOP’s related to Stability Department.
- Prepare, Update and Implement Method of Analysis, Stability Analytical Worksheets of finished products and their packaging material items.
- Check and approve the analysis test results and Analytical Worksheets for stability samples and approve the relevant Stability Data Record Sheet.
- Set daily and weekly plans for working within the section to ensure fulfilment of the target and best headcount and equipment utilization.
- Prepare monthly sample pulling plan for stability samples at the beginning of every month.
- Monitor and report KPI’s regarding Stability Department activities, analysts’ and senior analysts’ performance to quality operations head and QA Manager.
- Conduct, Prepare and Submit stability studies for all products manufactured in the site in response to regulatory authority (EDA) stability requirements for Variation, Registration or RE-registration purposes.
- Ensure stability testing of all products manufactured in site.
- Ensure proper detection, investigation and reporting of any failed stability results to relevant customers (QA, Regulatory, Quality Head, etc..)
- Ensure good housekeeping in the analytical lab, stability stores areas.
- Ensure proper induction and qualification of stability team members according to training SOP.
- Prepare and Review stability annual review report at the end of each year and raise its outcome to QA manager and quality operations head.

**Qualifications**:

- University graduate pharmacy or relevant.
- 6 years of experience in QC / Stability in the pharmaceutical industry.
- Good knowledge ofc GMP, GLP safety regulation and EDA regulatory guidelines.
- Good technical experience in analytical testing with its related aspects.
- Familiar with global Pharmacopeias (Ex. USP, BP, EP,etc.).
- Excellent Knowledge of English language
- Good communication skills.

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