QA Specialist

Sandoz is commited to helping millions of patients access biologic medicines
sustainably in areas including oncology. With a strong portfolio of eight
marketed biosimilars and a further ‎15+ in various stages of development,
Sandoz has an unparalleled heritage and extensive expertise in the
development, manufacturing and delivery of biosimilar medicines to patients
and healthcare community.

Would you like to work for a Global Generics and Biosimilar company and
contribute to our mission to extend and improve people's lives? Join Sandoz!

Your responsibilities include, but are not limited to:

Saudi licensed pharmacist & QP responsible for the product release in Saudi by
performing the following:
* Act as the company key point of contact for Health Authority Field Alert and voluntary recalls reporting for pharmaceutical products.
* Act as the 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 QA release responsibility
* Batch number & its compliance with CoA/batch certificate
* Availability of batch CoA & batch certificate

Support to implement and maintain the local Quality System in the areas of GMP
in accordance with the SDZ Quality Manual, the Quality Plan, and the local
regulatory requirements across GLS Cluster Countries

Ensure that all aspects of the handling/ storage and distribution of
pharmaceutical products in the Cluster comply with the requirements of the
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 GLS Cluster

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 GLS Cluster Countries including Export market QA departments across the
region for adopting best practices

Ensure oversight of GMP 3rd party vendors in the GLS Countries following
relevant processes

Ensure conduct of adequate training at the GLS Cluster Countries for GMP
related activities by defining, planning and supporting training activities.

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 GLS organization

Manage the Documentation management system across the GLS 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

Support in establishing and maintaining QA Agreements with all third parties
across GLS Cluster

Support/ back-up external inspections, complaints, recalls, counterfeits, and
product tampering according to the SANDOZ 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)

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment
and diverse teams representative of the patients and communities we serve.
Minimum requirements
Education: A university degree in life science or related field with a minimum
duration of four years. Must be eligible to act as Qualified Person under
local legislative requirements

Languages: English fluent in speaking / writing
Experience:Minimum ‎4- ‎5 years' experience in the pharmaceutical industry
(quality assurance, quality control, registration or production) or a directly
related field
Division
SANDOZ
Business Unit
Commercial OPS SIR SZ
Country
Saudi Arabia
Work Location
Riyadh
Company/Legal Entity
Sandoz Pharmaceuticals d.d.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No