Quality Assurance Specialist

Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Prepare Documentation for Batch Release of commercial Pharmaceuticals.

Major accountabilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.
• Support exception investigations.
• Review and approval of production, QC, and AS and T records.
• MBR review.
• Support OpEx improvement projects.
• Qualified Person – Executes batch release in compliance with registration.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Key performance indicators:

• On-time and GMP-compliant release of dosage forms.
• No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
• Successfully support continuous improvement projects.
• Executes batch release in compliance with registration.
• Functional Breadth.
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring.

Skills:

• Dealing With Ambiguity.
• GMP Procedures.
• QA (Quality Assurance).
• Quality Control (QC) Testing.
• Quality Standards.
• Technological Expertise.

Languages:

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Location: Remote, Switzerland

Functional Area: Quality

Job Type: Full time

Employment Type: Temporary (Fixed Term)

Shift Work: No

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