Quality Assurance Sr. Executive

2 weeks ago

المملكة العربية السعودية, Saudi Arabia 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.

**Role Summary**:
Quality Assurance person is responsible for providing evidence that all information necessary to determine that the product fit for the intended use is gathered evaluated and approved. To involve, coordinate and control the activity that fulfill the quality requirements.

**Responsibilities**:

- Review the batch record and identify any incomplete data and calculations, ensure that its content is completed and all process complies with the approved procedures.
- Check that any OOS, NCMR / Deviation, Change request related to the batch are recorded,investigated and disposed properly.
- Supervise QA In-process team for line Clearance, In-process checks and shop floor activities.
- Communicate to the different concern departments any findings observed during batch record audit.
- Report for any deviation observed during batch record audit.
- Decide the release or rejection of the batch based on careful evaluation of relevant documents.
- Provide active support to QA team for execution of validation and QMS functions.
- Communicate with SFDA for any query or response on regulatory related question.
- Managing activities related to controlled drugs as per SFDA guidelines including new manufacturing requests, new transfer requests and destruction requests.
- Registration of released finished goods batches in the IBRCS (Importing, Batch Release and Clearance System) as per Saudi Food and Drug requirements.
- Registration of released finished goods batches in SFDA RSD system.
- Submit the batch record to Document Control for archiving after reviewing and releasing are completed.

**Qualifications**:

- A minimum of 03 years experience in same operation of pharmaceutical.
- Master’s degree / Bachelor degree in Pharmacy.
- Professional Classification & Registration from SCFHS
- Knowledge of manufacturing instruments, equipment. PK and analytical studies are required.
- Excellent interpersonal, communication skills and team playing capability and ability to meet challenges and deadlines.
- Fluency in Arabic & English languages.

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