عربي

الصفحة الرئيسية وظائف في الامارات وظائف موزع في الإمارات العربية المتحدة موزع

قائد الفريق- فريق الجودة التابع والموزع

Julphar

تم نشره يوم 1 ديسمبر 2020

7 - 10 سنوات United Arab Emirates - United Arab Emirates

بكالوريوس العلوم (كيمياء) ، بكالوريوس صيدلة (صيدلة). أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


Must ensure end to end responsibility and completion of Tasks for distributor process (qualification, selection, oversighting and re-qualification).
Moreover, he/she will be responsible to face external quality audits regulatory/customer audits hosting and audit management.
Key responsibilities & Accountability:
Key Responsibilities
Setup of system for distributor management that ensures :
a. Local Complaint handling and Coordination activity (Receiving, investigating, response and closure).
b. Product Surveillance activity
c. Recall management
d. Corrective Action execution
e. Local market Release of products according to GMP and Julphar quality system when needed
f. Deviation and non-conformities handling.
g. Change control committee.
System in Place for following GDP at all warehousing activities.
Ensure compliance with current Good Manufacturing Practices, Good Documentation Practices, applicable ISO standards and other areas of mandatory regulatory oversight.
processes needed for the quality management system are established and maintained.
Maintain proper system related KPIs and trending in a way that allow continuous improvement culture.
Evaluation of all distributors through which Julphar is channeling their Finished goods or carrying out any storage activities.
Ensure product storage is compliant with GDP and GCC/WHO guidelines.
Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); in compliance with regulations.
Establish SOP's based on QMS, and revise them as necessary. Manage SOP's based on related procedures
Lead team for RA/PV intelligence to ensure the final submitted documents to HAs are in compliance with procedures and guidelines.
Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide support as a scientific/technical resource for raised changes and projects, share experience with colleagues
Review and approve as quality assurance representative for PV(Pharmacovigilance) relevant documents.
Ensure that any health authorities communication are correct, tracked and implemented as committed.
Monitor monthly performance and function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance are met.
Responsible for preparation, execution and aftercare of any such Improvement Projects within the assigned work area.
Qualifications:
- Education
Bachelor s degree in Pharmacy / Chemistry, Masters degree is a definite advantage
- Experience:
Experience of minimum 7-10 years in Pharmaceutical Industry preferably in Quality Management systems. Must have proven experience in in market quality and distributor management
Previous experience in a similar role and with experience in a Pharmaceutical/ Healthcare Industry is preferred
- Training:
Key Competencies:
In terms of Competency you are highly result oriented with strong sense of accountability & ownership,
Excellent communication, interpersonal and presentation skill.
Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
Business acumen partnered with a dedication to legality is essential for better fitment
Customer-oriented approach with strong aptitude and innovative flair of mind
Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities an analytical mind able to "see" the complexities of procedures and regulations
Strong Manpower handling skills and having effective team communication and motivational skills.
Capable of suggesting ideas in a structured manner and having good Command on English language.
You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
Technical Competencies:
Extensive Knowledge in cGMP ,GDP ,PV and regulatory guidelines.
Knowledge in strategic and business planning will be an advantage
Must be experienced in managing complex and sensitive operational challenges.
Knowledgeable with SOP writing, GMP compliance.
Strong IT skills, inter personal skills and technical knowledge.


هندسة

الكلمات الرئيسية

Team Leader- Affiliate & Distributor Quality Team

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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