Novartis
Pharmaceutical
QualityAssuranceOperationsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Assurance Operations Specialist at Novartis. Skills: Quality Assurance, GMP compliance, Batch release. Review and approval of batch manufacturing records. Review and assessment of analytical results”
What You'll Achieve.
Timely and compliant batch release
Industry & Context.
Problem Solving Skills
What They're Looking For.
Must Have
Solid experience in pharmaceutical or GMP-regulated environment, knowledge of GMP requirements, Fluent in German
Nice to Have
Experience in Quality Assurance or quality control
What You'll Do.
Review and approval of batch manufacturing records
Review and assessment of analytical results
Control and verification of batch documentation
Support audits and inspections
Support investigations related to deviations
Support OOS/OOE investigations
Support complaint investigations
Support CAPA management activities
Support changes to processes
Support changes to documentation
Support changes to quality requirements
Preparation of certificates
Preparation of reports
Preparation of quality-related lists
Review of certificates
Review of quality-related lists
Communication with internal departments
Coordination with internal departments
Communication with external partners
Coordination with external partners
Execution of tasks in a timely manner
Execution of tasks in an efficient manner
Execution of tasks in a GMP-compliant manner
How You'll Work.
Team & Collaboration
Internal departments; External partners
Communication Scope
Communication skills
Full Job Description
**Job Description Summary** The QA Operations Specialist is responsible for providing quality assurance support for drug substance manufacturing activities, with a strong focus on batch record review and GMP compliance. The role ensures timely and compliant batch release, supports investigations and audits, and contributes to maintaining the Novartis Quality Management System. **Job Description** **Key Responsibilities** * Review and approval of batch manufacturing records as part of the batch release process * Review and assessment of analytical results, certificates, and specifications * Control and verification of batch documentation and quality records * Support audits, inspections, and regulatory interactions, investigations related to deviations, OOS/OOE, and complaints * Support CAPA management activities and changes to processes, documentation, and quality requirements * Preparation and review of certificates, reports, and quality-related lists * Communication and coordination with internal departments and external partners * Execution of tasks in a timely, efficient, and GMP‑compliant manner **Obligatory requirements:** * Solid experience in a pharmaceutical or GMP‑regulated environment. * Experience in Quality Assurance or quality control is preferred. * Strong knowledge of GMP requirements. * Results‑driven mindset with continuous improvement focus * Strong customer focus and communication skills * Fluent in German, basic English In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 47.532,24/year (on a full-time basis). We also offer a potential market oriented excess payment in line with y
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