Quality Assurance & Regulatory Affairs Specialist

329098BR
Oct 06, 2021
Slovakia

Job Description

We are Sandoz and our aim is to be in the top 3 Generic & Biosimilars companies on the market by 2023.

Quality Assurance Specialist ensures the implementation of Company corporate Quality Standards in CO SK to be compliant with Novartis Quality standards/Sandoz Standards.
He/she also provides Quality oversight and governance to ensure proactive compliance with Novartis and Health Authority GxP requirements, and to meet business expectations. He/she prevents quality or regulatory non-compliance issues 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's reputation. QA Specialists closely cooperates with Regulatory Affairs and Country Quality Assurance Lead.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Reporting of discrepancies between MA and SAP Reg Database (safety, quality)
• Supporting other departments with information and data Responsible to manage Printed Packaging Materials, Collaboration with Pharmacovigilance, Collaboration with Medical Department on Clinical Activities
• QA oversight over Pharmacovigilance / Novartis Patient Safety to extend aligned with Sandoz d.d.
• Ensuring the approvals of Artworks and proper implementation of any updates to production (One ART, AFD)
• Permanent reporting to Pharmaceutical Affairs department and company management / Quality Committee
• Regular communication with Drug Regulatory Affairs Manager (supply limiting Variations, Safety implementation)
• Ensuring that Quality System and all Standard Operating procedures (SOPs) are in place for all GXP related activities and that compliance is maintained (revision plan in place) through training and internal audits & self-inspections
• Performing investigation of deviation in Sandoz SK and ensures Escalation process
• Ensuring that all activities related to »complaints«, »recalls« are performed in accordance with the local regulations and Sandoz standards

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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SANDOZ
COMMERCIAL OPS EUROPE SZ
Slovakia
Bratislava
Quality
Full Time
Regular
No
329098BR

Quality Assurance & Regulatory Affairs Specialist

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