QA Specialist

3 weeks ago

Riyadh, Saudi Arabia Sandoz Full time

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

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