Novartis

Pharmaceutical

QualityAssuranceOperationsSpecialist

€48k+ Kundl, Austria PART TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Pharmaceutical
Problems you'll solve

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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