Ipqa Specialist

**وصف الوظيفة**:
**Overall Purpose of the Job**:
Responsible for recording the quality assurance activities, follow up toll production process steps, investigate the production and process problems, complaints received for those products and participate in solving them and assure recording of all the critical production steps in the batch records.

**Primary Tasks**:

- Follow up the good storage practices in toll sites warehouses and relevant SOPs.
- Follow up and assure that the checklists of the RH, temperature at the different places at the warehouse and production areas as per the relevant SOPs.
- Perform inspection on the destruction process for the rejected finished products, raw materials and packaging materials.
- Perform inspection on the raw and packaging materials and ensure their testing conformance with the acceptance criteria.
- Perform inspection and assure the proper implementation of gowning procedure according to the SOP.
- Perform inspection / weekly review on different manufacturing activities in the toll sites production areas and their conformance with the relevant SOPs and the agreed quality contracts between Orchidia and the toll manufacturer.
- Check the environmental conditions and assure their fulfillment for the working conditions’ needs.
- Assure that different IPC tests required during different production stages as per the manufacturing batch record.
- Responsible for assuring that samples required by the bulk, semi-finished and finished products are sampled, tested and conforming to the controlled specs in place.
- Reviewing batch records after process completion.
- Participate in any complaint investigation to identify the root causes of the problem and solving it with the processes owners
- Participate in internal or external audit whenever requested, and prepare the needed reported points for the conducted audits
- Work through, follow and adhere to safety instructions and requirements.
- Work according to GLP, GMP and GDP rules.
- Participate in the EHS activities. Via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
- Participate in Orchidia’s process controlling and utilities inspection activities [as requested].
- Assure, check and follow up Orchidia’s good storage practices.
- Participate in the deviations which occurs at all toll sites, affecting the business and market needs.
- Follow up the CAPAs raised with toll sites till effective implementation is assured.

**المهارات**:

- Bachelor’s degree in pharmaceutical sciences or sciences.
- From 1 to 3years of experience in pharmaceutical industry and operations.
- Experience in toll is preferred.
- Understanding of methodologies and best quality assurance practices.
- Knowledge of documentation reviews and requirements analysis.
- Ability to troubleshooting and resolving complex issues effectively.
- Ability to work well through others.
- Ability to meet workloads and projects’ deadlines.
- Excellent English, verbal / written communication.
- Excellent computer skills.

**المؤهلات العلمية**:
Pharmaceutical Industries

**تفاصيل الوظيفة**:

- مكان الوظيفة- القاهرة, مصر- الدور الوظيفي- التصنيع- الحالة الوظيفية- دوام كامل- نوع التوظيف- موظف- يتطلب إدارة موظفين آخرين- نعم- عدد الوظائف الشاغرة- 2**المرشح المفضل**:

- المستوى المهني- متوسط الخبرة- عدد سنوات الخبرة- الحد الأدنى: 1 الحد الأقصى: 3- منطقة الإقامة- القاهرة, مصر- الجنس- ذكر- الجنسية- مصر- الشهادة- بكالوريوس