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.
Quality Assurance Manager – Gulf Cluster
We are looking for a MOH UAE Licensed Pharmacist to join our UAE Team who will be responsible for:
Ensure all quality-relevant processes within Gulf Country Organization are compliant and that any non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues. Provide Quality oversight and governance to ensure proactive compliance with Novartis and Health Authority GxP requirements, and to meet business expectations. Prevent quality or regulatory non-compliance issues un areas of responsibility which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation. Participate in cross-divisional standardization and efficiency gains through innovation and operational excellence projects within Areas of responsibility.
Major Accountabilities of the Role will be :
1.0 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
2.0 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
3.0 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.
4.0 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
5.0 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.
6.0 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
7.0 Ensure oversight of GMP 3rd party vendors in the CPO UAE and Gulf Countries following relevant processes
8.0 Ensure conduct of adequate training at the Gulf Cluster Countries for GMP related activities by defining, planning and supporting training activities.
9.0 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.
10.0 Ensure that deviations and incidents are properly managed in QMS system, and that escalation is performed when required.
11.0 Manage the change control process across the Gulf organization
12.0 Manage the Documentation management system across the Gulf organization following relevant processes/ systems
13.0 Ensure implementation of corrective actions resulting from inspections by Health Authorities, Group Quality Operations, and other self-inspections s relevant
14.0 Establish and maintain QA Agreements with all third parties across Gulf Cluster Countries.
15.0 Support/ back-up external inspections, complaints, recalls, counterfeits, and product tampering according to the Novartis Corporate Quality Manual and local written procedures.
16.0 Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, and distributors)
Commitment to Diversity & Inclusion:
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
To apply for this job please visit sjobs.brassring.com.