عربي

الصفحة الرئيسية وظائف في الامارات وظائف اختصاصي جوده عاليه في الامارات اختصاصي جوده عاليه

QA Senior Specialist (QC oversight) - Sterile

Julphar

تم نشره يوم 4 فبراير 2021

6 - 7 سنوات United Arab Emirates - United Arab Emirates

بكالوريوس في التكنولوجيا/ الهندسة. أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


Maintain oversight of the QC activities including testing, Out Of Specifications (OOS), Out Of Trend (OOT) , perform investigations to maintain GMP and quality standards.
Key responsibilities & Accountability:
Ensure effective and full implementation of GMP related requirements to Laboratory Practices
Comply with Julphar information security and policies
Comply with Data integrity, privacy declarations and procedures
Investigate lab associated deviations and OOS
Providing CAPA for relevant departments from deviation reporting to close identified gaps
Contribute in Technical Risk Assessments for analytical method validations
Maintain all system inspection ready & presenting lab deviation & OOS/OOT reports to internal & external audits
Escalate of any schedule predicted delays, deviation outcome issues in a timely manner for Team leader & Management decision making
Actively participate & value add in continuous improvement initiatives.
Support the CAPA implementation and monitoring its effectiveness
Conduct & support the for On Job training wherever needed
Reviewing and approving master technical documents including:
Raw Material Specification (RMS)
Raw Material Purchase Specification (RMPS)
Standard Test Method (STM)
Test Method Validation Protocols (TMRP)
Test Method Validation Reports (TMVR)
Standard Operating Procedure (SOP) QA/QC
Stability Protocols/Reports
Lead and closing up laboratories investigation for:
Raw Material and finished product analysis out of specifications (OOS)
Stability out of specifications (OOS)
Microbiology deviations
Deviations related to QC & QA Operations
Market Complaint
Any other responsibilities assigned by QA Head and QA Manager.
Core Competency
High on communication and collaboration , 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.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Good command in English (Communicating, writing and speaking)
Good prioritizing skills and being able to make a just decision also in case of (time) pressure
Flexible learning abilities
Excellent knowledge of cGMP and strong focus on clients and quality/compliance;
Excellent root cause analysis capabilities, Innovative abilities, creative, strong drive to improve
Must be highly organized, self-motivated to learn new things and implement them in building or updating quality system for Pharmaceuticals
Process the ability to develop and maintain an effective working relationship with internal and external sections, function as team player and comply with company policies.
Qualifications:
- Education
Master Degree in (Bio)Pharmacy or related other science
- Experience:
A minimum of 6+ years of relevant experience in similar industry (preferably in a sterile environment)
Must have a background in Biotech/ sterile QC testing data review/ trending
- Training:
Key Competencies:
Preferable to have prior experience with Insulin production process
Preferable experience in Minitab
Have strong leadership skills.
Technical Competencies:
Data Analytics/ Experience in Statistical Process Control


نوعية / تجربة / جواب / مراقبة الجودة / مفتّش

الكلمات الرئيسية

QA Senior Specialist (QC oversight) - Sterile

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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