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NCQ (Novartis Country Quality) Manager.
About the job
About The Role
About 108,000 people of more than 140 nationalities working at Novartis around the world are committed to improve and extend people’s lives. Novartis products reach nearly 800 million people globally, and we are finding innovative ways to expand access to our latest treatments.
Your Responsibilities:
Your responsibilities include, but not limited to:
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
- Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly.
- Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely manner.
- Escalate any issues or instances of instability per the Novartis escalation policy and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
- Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.
- Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products.
- Support launches of product in close collaboration with BD& L partner and/ or development organization. Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
Commitment to Diversity & Inclusion:
إقرأ أيضا:مطلوب مسؤول مخزن لدى شركة ستارز التجارية في ضواحي القدسWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
What you’ll bring to the role:
- 5-7 years of accumulative experience in a similar role / QA related functions, in Multinational Pharmaceutical Companies.
- Minimum of 1-3 years of People Management Experience.
- Experience in Production and/or Regulatory.
- Fluency in English and Arabic Languages.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
إقرأ أيضا:Job Opportunity: Educational Designer in Amman, JordanImagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
إقرأ أيضا:مطلوب محاسبة لدى شركة الامين الحديثة الاستثمارية في رام اللهOperations
Business Unit
QUALITY
Work Location
Cairo
Company/Legal Entity
NOV PHARMA EGY
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
