عربي

الصفحة الرئيسية وظائف في الامارات وظائف اخصائي جوده في الامارات اخصائي الجودة

QA Specialist-(Batch Release & Review)

Julphar

تم نشره يوم 9 فبراير 2021

6 - 8 سنوات United Arab Emirates - United Arab Emirates

Other(Other), Bachelor of Pharmacy(Pharmacy), Bachelor of Technology/Engineering(Any, Chemical), Bachelor of Science(Any, Chemistry). أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


To adhere with the cGMP principles and to ensure effective measures taken for Good Documentation practices in Batch Documents.
Responsible to perform Batch Document Review for all dosage form related to all departments (Production, Packaging, Q.C., Store, and Eng.) and to ensure timely completion of document review activity.
Key responsibilities & Accountability:
Responsible for reviewing and auditing all completed Batch records at all process stages for all dosage forms & to ensure the conformance as per the requirement of cGMP and related SOP s
Responsible for review of Batch Documents as per the related checklist of the SOP TCS-003.
Responsible to check the details of vendor used in the batch as per Approved vendor list.
Responsible to update the daily tracker for the observations identified and follow up with related departments for corrections in Manufacturing/Packaging documents.
Responsible to ensure any deviations/investigations occurred in the batch & documented the deviation/investigation details prior to entry of batch record compliance in SAP
Responsible for Release of finished product in SAP.
Responsible to provide the details of batches entered in SAP as a part of compliance at the end of the day for final release.
Responsible to issue the batch release certificate for final batch approval.
Perform any other work assigned by the Team Leader/ QA Manager.
Qualifications:
- Education
Education: 4 years Bachelor degree or Master s Degree in Pharmacy/Chemistry / Chemical Engineering is mandatory
MBA or MS in Quality Management a plus
- Experience:
Experience of minimum 6-8 years in pharmaceutical industry in Quality Management systems is mandatory
- Training:
Key Competencies:
High on communication and collaboration and team work , having an ability to manage multiple stakeholders at a time.
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Excellent communication skills.
Good command in English (Communicating, writing and speaking)
Technical Competencies:
Solid Technical knowledge with strong implantation skill , people management skill.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping.
Methodical and diligent with outstanding planning abilities an analytical mind able to "see" the complexities of procedures and regulations.
Business acumen partnered with a dedication to legality.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Advanced knowledge of Product/process/quality and able to identify the gaps in the areas to improve the systems.
KPI management, proven experience in conducting Risk Assessments.
Problem Solving and high agility on taking right scientific decisions.
Advanced knowledge of Manufacturing operations, Product and GMP/Quality systems


نوعية / تجربة / جواب / مراقبة الجودة / مفتّش

الكلمات الرئيسية

QA Specialist-(Batch Release & Review)

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.

المزيد
عرض تفاصيل الاتصال
معلومات إضافية مطلوبة

طلب صاحب العمل بعض المعلومات الإضافية مع طلبك للحصول على هذه الوظيفة

تسجيل الدخول الى نوكري غلف

مواصلة استخدام

ستبقى جميع أنشطتك سرية

أو