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QA - Validation Specialist (Process & Cleaning)

7 months ago

مصر, Egypt Orchidia Pharmaceutical Industries Full time

**وصف الوظيفة**:

- Assure of the conforming of the facility, utilities, equipment and machines to perform the validation activities.
- Analyze all needed data and prepare reports for quality assurance supervisor.
- Prepare plan for revalidation activities
- Supervise qualification activities during execution.
- Prepare validation plans/protocols in cooperation with concerned departments for the production processes such as:

- Process validation.
- Cleaning validation.
- SIP validation.
- Filtration validation.
- Any relevant activities required by the regulatory authorities.
- Prepare VMP for the facility as per latest guideline.
- Prepare all documents/SOPs needed for different validation activities.
- Review all supportive documents needed during the validation processes.
- Supervise the investigation team in items related to validation and qualification activities
- Prepare action plan.
- Participate in CAPA system.
- Follow up implementation.
- Work through, follow and adhere to safety instructions and requirements.
- Work according to GLP, GMP and GDP rules.
- Shall be consulted and participated in the EHS management system and its improvement elements.

**المهارات**:

- Bachelor’s degree in pharmaceutical sciences or science.
- From 3 to 6 years of experience in pharmaceutical industry and operations.
- 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 project deadlines.
- Excellent English, verbal / written communication.
- Excellent computer skills.

**المؤهلات العلمية**:
Validation (Process & Cleaning)

**تفاصيل الوظيفة**:

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

- المستوى المهني- متوسط الخبرة- عدد سنوات الخبرة- الحد الأدنى: 3 الحد الأقصى: 6- منطقة الإقامة- القاهرة, مصر- الجنس- ذكر- الجنسية- مصر- الشهادة- بكالوريوس