QA Compliance Section Head

7 months 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.**Basic Purpose of the Job**:

- Lead all compliance activities in the quality assurance department to ensure achievement of the agreed-on objectives including the compliance of all effectively implemented procedures within the ALJP factory with the WHO cGMP & EDA regulations.

**Main job responsibilities**:

- Lead CAPA management process to ensure effective and timely completion & assess its effectiveness.
- Ensure planned change controls are effectively handled in a correct manner as per SOPs.
- Manage company Internal audits and ensure the effectiveness of self-inspection processes.
- Ensure that all deviations/incidents are investigated, assessed, and appropriately corrected.
- Ensure local and global regulatory conformance and alignment.
- Ensure deployment of global references and their effective implementation.
- Handling all activities of any product recall or market-compliant.
- Ensure completion of supplier qualification activities.
- Ensure effectiveness of the APR & related activities.

**Qualifications**:

- University graduate pharmacy, or science.
- Minimum of 5:8 years’ experience in a similar field especially in sterile manufacturing.
- Up to date knowledge of current GMP, EDA Regulatory requirements, WHO & ICH guidelines.
- Preferable knowledge with SAP system.
- Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
- Good command of English (spoken and written).


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