Quality Assurance Officer Operations (m/w/d)

Band

Level 3

 

Job Description Summary

#LI-Onsite
The Quality Assurance Officer Operations manages Quality aspects and projects within area of responsibility and ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

 

Job Description

Major Accountabilities:

• Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.
• Provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes.
• Support continuous quality improvement initiatives for manufacturing operations by collaborating with production, QC, engineering, and supply chain teams to implement and optimize processes that enhance efficiency.
• Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities, while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed.
• Provide cGMP and associated training to any other quality members and other operational areas as needed.
• Support exception investigations -Review and approval of production, QC, and AS and T records.
• Support OpEx improvement projects Qualified Person and executes batch release in compliance with registration

Obligatory Requirements:

• Education: Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree
• 3+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations.
• 2+ years of experience in a Quality Assurance role. It is important to have QA and/or QC experience with environmental monitoring & cleanliness zones.
• Fluent English and German, written and spoken.

You’ll receive:

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Wellbeing), employment at Top SI Employer, Unlimited learning and development opportunities.

Commitment to Diversity and Inclusion:

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

 

Skills Desired