عربي

الصفحة الرئيسية وظائف في الامارات وظائف مساعد مدير في الإمارات مدير مساعد

مدير مساعد

Julphar

تم نشره يوم 15 يناير 2021

8 - 10 سنوات United Arab Emirates - United Arab Emirates

أي تخرج. أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


The role will adhere with the cGMP principles and to maintain them in an effective manner. He/she will be leading and managing the company compliance project to alight the registered dossier information with the current plant documentation (Product Remediation).He/she will be responsible for handling and managing change control process (impact assessment, variation planning and submission), leading the CAPA's deviations and nternal Audits, assisting the Liaison Team for the assessment of needed variations to set up a strategic submission plan, assisting the variation team for post approval changes (variations) & related queries from Health Authorities, & assisting the review team in variation files revision before dispatching to Liaison Team.
Key responsibilities & Accountability:
-Follows SOPs and recent guidelines for optimal compliance of all products registered for Julphar.
-Determines the action plan based on periodic meeting with related stakeholders for products compliance and documents alignment of registered products in UAE.
-Liaises with multiple stakeholders to arrange all documents required for variation submission in COO.
-Responsible for evaluation of variation packages received from stakeholders for products compliance in COO and ensuring variation submissions and approval to UAE-MOH.
-Responsible for regulatory impact assessment for change controls initiated from RA and other stakeholders, and determining submission plan based on assessment and specific country requirements.
-Responsible for follow up with RA Team to close raised CAPAs and Deviations, managing the internal audits.
-Assists the Liaison Team in planning and strategy preparation of all related variations to UAE-MOH and to all other markets after approval from COO through periodic discussion for monthly plan and products prioritization.
-Provides support and guidance for variation team on notification files and additional inquiries compilation and submission to different markets as and when required.
-Responsible for assisting in variation files assessment and review before dispatching to liaison team to assure conformance of submitted data within given timeline.
-Reviews of MFM received based on Technical Operation Production Plan.
-Responsible for the preparation of Variation status as requested from different stakeholders.
-Performs other related duties/additional tasks as required by management.
Qualifications:
- Education
-Must have degree in Pharmacy
- Experience:
-Minimum of 8 years' experience pharmaceutical industry is required.
- Training:
Key Competencies:
-Excellent written and verbal communication skills.
-Time management and leadership skills.
Technical Competencies:
-Good knowledge of MS Office (Word, Excel, Powerpoint), Adobe PDF, eCTD Software (Pharma ready).


الكلمات الرئيسية

مدير مساعد

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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