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Senior Production Specialist
6 months ago
**وصف الوظيفة**:
**Overall Purpose of the Job**:
Maintain work flow by monitoring every step of the production process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points.
**Primary Tasks**:
- Prepare operational schedules and coordinate manufacturing activities.
- Monitor the production processes and its conformance to regulations and identifies any deviation and trend.
- Ensure that plant facilities, utilities, equipment are maintained well to meet production plan.
- Maintain batch record and relevant documents to ensure that all production steps are performed correctly, signed by production staff and quality assurance members.
- Prepare plan for process validation and cleaning validation and execute the validation plan in coordination with validation team.
- Keep tracking step by step each operation during production process and recording of the required data in the log book and review it.
- Ensure that all rules and regulations regarding GMP are followed.
- Monitor safety programs to eliminate industrial accidents.
- Document procedures used to assemble; process and test company's products.
- Monitor effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity.
- Supervise preparation, filtration and autoclaving processes.
- Follow up integrity testing for used filters according to authorized SOP.
- Follow up availability of primary packaging materials for filling machine.
- Follow up cleaning and fumigation of sterile area.
- Monitoring of RH%, temperature, and differential pressure inside sterile area.
- Batch record review, revise logbooks and other documents related to sterile area.
- Represent production department in validation team.
- Represent production department in internal audit team.
- Conduct on job training for operators about GMP regulations during cleaning and operation of filling machines.
- Follow up receiving of primary packaging materials for CAM and BOTTLE PACK filling machine.
- Follow up machine filling rates.
- Complete filling stage in batch record.
- Follow up recording in logbooks.
- Receive raw materials from warehouse.
- Complete reconciliations of capping, over printing, check weigh, labeling and packaging stages in batch record.
- Follow up record in capping, over printing, check weigh, labeling and packaging logbooks.
- Work through, follow and adhere to safety instructions and requirements in production areas.
- 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.
From 3 to 6 years of experience in production (Sterile Production Area) in pharmaceutical firm.
A basic understanding of production processes and production equipment.
Good track record on meeting/ exceeding customer expectation.
Good planning and management by objectives.
Excellent English, verbal/written communication.
Ability to work well through others.
Excellent computer skills.
**المؤهلات العلمية**:
Pharmaceutical Science or Science
**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- مبتدئ الخبرة- عدد سنوات الخبرة- الحد الأدنى: 3 الحد الأقصى: 6- منطقة الإقامة- القاهرة, مصر- الجنس- ذكر- الجنسية- مصر- الشهادة- بكالوريوس
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