Quality Assurance- Ipc

7 days 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**:
Ensure adherence to quality assurance system and GMP in all facility areas.

**Responsibilities**:

- IPC testing during all steps of product manufacturing in accordance with governance SOPs.
- Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
- Ensure implementation of procedures of batch manufacturing and packaging documents, specifications & SOPs.
- Monitor calibration of production equipment and IPC testing instruments.
- Review batch related documentation for completeness, correctness, and compliance to approved standards.
- Report any observed incidents during routine production and follow up its correction and corrective action.
- Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing and packaging processes.
- Participate deviations, complaints, OOSs & OOTs in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
- Ensure identification and rejection of non-conforming materials/products according to GMP standards.
- Coaching operators to ensure that quality mindset is embedded in their day to day activities.

**Qualifications**:

- University graduate pharmacy, or science.
- Minimum of 1- 3 years’ experience in a similar field especially in sterile manufacturing.
- Ability to work night shifts is a must.
- 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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