Quality Assurance Manager - Gulf Cluster
Description
Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With a strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
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Job Details
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- Title : Quality Assurance Manager
- Company Name : Novartis
- Industry: Medical
- Career: Permanent
- Job Location: Dubai
- Salary: Will be discuss
- Experience: Min 5 years experience
- Job Type: Full Time
- Gender: Male/Female
- Nationality: Any
Responsibilities
- UAE licensed pharmacist & QP responsible for the product release in UAE by performing the following:
- Act as the CPO QP with the release authority formally delegated from the organization to ensure that all finished products and are released in accordance with the registered specifications and are released to the market in accordance with local/international regulations and ensure that a respective Change Control procedure is in place.
- Complete the Regulatory compliance checks for all received batches prior to release (Finished product shelf life: Registered / actual, should be checked together with Manufacture date/Expiry date/ Compliance of labelled storage conditions with registered storage Conditions/ safety label changes & artworks)
- Ensure performing incoming duty of care check for imported finished goods of products within CPO QA release responsibility
- Batch number & its compliance with CoA/batch certificate
- Availability of batch CoA & batch certificate
- Implement and maintain the local Quality System in the areas of GMP in accordance with the Novartis Quality Manual, the Quality Plan, and the local regulatory requirements across Gulf Cluster Countries
- Ensure that all aspects of the handling/ storage and distribution of pharmaceutical products in the Gulf Cluster countries comply with the requirements of the Novartis Pharma Corporate Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- In cooperation with local RA & PS, keep abreast of regulatory requirements, and update local management and CPO QA on the possible ramifications of regulatory changes and impact to relevant processes across Gulf Cluster Countries
- Ensure Green Key Quality Indicators (KQIs) related to GxP activities under responsibility and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
- Establish a good working relationship with the Supply Chain Management (SCM) for Gulf Cluster Countries including Pharma Services SCM and QA departments across the region for adopting best practices
- Ensure oversight of GMP 3rd party vendors in the CPO UAE and Gulf Countries following relevant processes
- Ensure conduct of adequate training at the Gulf Cluster Countries for GMP related activities by defining, planning and supporting training activities.
- Oversight, supervise and co-ordinate third party activities across Gulf Cluster and ensure that third party manufacture (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
- Ensure that deviations and incidents are properly managed in QMS system, and that escalation is performed when required.
- Manage the change control process across the Gulf organization
- Manage the Documentation management system across the Gulf organization following relevant processes/ systems
- Ensure implementation of corrective actions resulting from inspections by Health Authorities, Group Quality Operations, and other self-inspections s relevant
- Establish and maintain QA Agreements with all third parties across Gulf Cluster Countries.
- Support/ back-up external inspections, complaints, recalls, counterfeits, and product tampering according to the Novartis Corporate Quality Manual and local written procedures.
- Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, and distributors)
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Requirements
Education:
A university degree in life science or related field with a minimum duration of Five years. Must be eligible to act as Qualified Person under local legislative requirements ( Licensed pharmacist)
Languages:
English fluent in speaking / writing
Experience:
Minimum 5 years’ experience in the pharmaceutical industry (quality assurance, quality control, registration or production) or a directly related field
About Company
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.
How to Apply?
Interested candidates who wish to know more details about latest jobs at Novartis and to apply for Novartis directly - View & Apply
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