عربي

الصفحة الرئيسية وظائف في الامارات وظائف أخصائي الجودة العليا في الإمارات اخصائي جوده عاليه

الجودة ريال متخصص في الموقع (محطات التكنولوجيا الحيوية)

Julphar

تم نشره يوم 8 ديسمبر 2020

5 - 10 سنوات United Arab Emirates - United Arab Emirates

أي تخرج، بكالوريوس علوم، بكالوريوس في التكنولوجيا/الهندسة، بكالوريوس الصيدلة (الصيدلة). أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


Will adhere with the cGMP principles and perform Quality reviews as per Approved SOPs
Key responsibilities & Accountability:
1. Collaborate with Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure Product Quality.
2. Perform a quality review on batch documentation received from manufacturing / packaging sites.
3. Perform a quality review of log books.
4. Involve/Lead in the investigations of site deviations/Market complaints/OOS and ensuring effective root cause analysis and assigning of appropriate CAPAs.
5. Prepare and review of Annual Product Quality Review reports.
6. Participation in Internal and Regulatory audits.
7. Compliance to current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GDP).
8. Collaborates with functional departments to resolve issues and maintain compliance.
9. Actively participate in continuous improvement initiatives.
10. Have solid experience in microbiology and drug substance biotechnology manufacturing process (Growth Hormones and Mabs)
11. Have good knowledge of risk assessment principles and product assessment
Qualifications:
- Education
Bachelor/Master degree in Science/Pharmacy/Biotechnology
- Experience:
5-10 years in pharmaceutical industry preferably in Quality assurance or Production process having Biological Drug substances manufacturing.
Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.
Flexible to work in all Shifts and not sensitive to B-Lactams
- Training:
Key Competencies:
Strong written and verbal communication skills for English language. Basic IT skills and knowledge in Microsoft office (word, excel, etc.)
Honesty & Integrity Self-confident.
Document (SOPs) and investigation Reports writing in English.
Technical Competencies:
Knowledgeable with Pharmaceutical cGMP Guidelines


هندسة

الكلمات الرئيسية

Quality Sr Specialist Onsite (Biotechnology plants)

الدخول للتقدّمسجّل وقدّمقدّم بدون تسجيل

ابلاغ عن هذه الوظيفة

تنبيه: نوكري غلف فقط منصّة يجمع بين كل من الباحثين عن عمل و أصحاب العمل. ننصح المتقدمين للوظائف التحقق من شرعية أصحاب العمل المحتملين. نحن لا ندعم أي مطالبات لتحويل الأموال و ننصح بشدة ضد الإفصاح عن اي معلومات شخصية أو مالية.و ننصح أيضا زيارة تحذير أمني للمزيد من المعلومات. إذا تشك في أي غش أو احتيال اتصل بنا على abuse@naukrigulf.com

Julphar

Established in 1980 in the UAE, Julphar Gulf Pharmaceutical Industries is the largest generic pharmaceutical manufacturer in the Middle East and North Africa. Beginning its journey with the first stand-alone facility that produced 5 products, Julphar now operates 15 globally certified manufacturing facilities. Distributing medicines to more than 40 countries globally, the company maintains a broad range of product portfolio that includes categories such as Pediatric Primary Care, Wound, Anemia and Women Care, Cardiopulmonary Care, Consumer Care, Adult Primary Care, Gastro Care and Pain Management. The company holds the vision to be recognized as the leader for pharmaceutical products and contribute to a better healthcare in the Middle East and Africa region.



Julphar’s 13 facilities are based in the UAE while other manufacturing units are available in Bangladesh, Ethiopia and Saudi Arabia as a part of its international expansion plan. In 2012, the company also launched the only one of its kind Active Pharmaceutical Ingredient (API) manufacturing facility in the Middle East named as Julphar Diabetes, which supported its positioning among the largest manufacturers of insulin in the world. Julphar has bagged several awards and ISO9001 and ISO14001 accreditations. It works closely with regulatory bodies, such as the US Food and Drug Administration (FDA) and the UAE Ministry of Health (MOH) to ensure that all their practices are aligned with the international requirements.



Julphar employs around 3,000 people around the world and believes that its corporate results are achieved due to its dedicated employees. Working for Julphar offers an opportunity for career and personal development.

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