Quality Technical Assistant

2 days ago

مصر, Egypt Jamjoom pharma Full time

**Responsibilities**:

- Gather information from all departments prepare a technical report about the status of the factory & submit it to quality Operations head for review.
- Prepare any technical letter or request to be submitted to EDA or NODCAR.
- Prepare monthly report about EDA Visits, samples withdrawn to NODCAR and products approvals.
- Inform all factory departments about EDA new decisions & regulations & ensure it is interpreted correctly.
- Follow up implementation of EDA regulations & steps required in case of (re-registration of a product, registration of new supplier, new composition, or new batch size for a pre-registered product).
- Communicate, arrange & follow up with EDA inspectors for weekly visits or any requested visits.
- Prepare & review all the required documents (PBRs - COAs - Registration license - etc...) for EDA inspector weekly visits.
- Archiving all EDA inspector visits reports, conformities, or new decisions received.
- Prepare the samples withdrawn by the EDA inspector, prepare the standards & documents required & submit all these to NODCAR.
- Follow up for conformity status of NODCAR submitted samples & any additional requirements need for obtaining the conformity report.
- Review stability files for any product before submitting to Registration department.

**Required qualification**:

- University graduate or pharmacy, or science.
- Minimum 4 years’ experience in pharmaceutical factory or scientific office.
- Working experience with EDA inspectors & Handling of NODCAR samples is preferred.
- Excellent business letters & reports writing skills.
- Excellent Computer skills (Specially Word and Excel)
- Up to date knowledge of current GMP & good documentation practice as per EDA Regulatory requirements, WHO & ICH guidelines.
- Excellent communication skills.
- Familiar with SAP system
- Good command of English (spoken and written)
- Self-motivation, empowerment, and adaptation to business changes

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