QA Operations Expert

Healthcare Businesswomen’s Association; Österreich; Vor Ort; EUR 59.000 - 72.000; Vollzeit

Zusammenfassung

Novartis is seeking a quality-focused professional to support introduction of autoinjector devices to the commercial phase in Schaftenau, Austria. You will manage device components and primary packaging suppliers from a quality perspective, ensuring cGMP compliance and adherence to QA agreements and regulatory requirements.

Responsibilities include reviewing production, QC and AS&T records, approving DHF/DMR documents, and supporting investigations and OpEx projects.

Qualifikationen

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• At least 3 years or more experience in MS&T, QC, QA or medical device industry.
• Experience in relevant operations or third party management.
• Fluent knowledge of English language (written and spoken).
• Flexibility to work in a fast paced, quickly changing work environment.

Aufgaben

• Responsible for third party management of device component and primary packaging material suppliers.
• Responsible for evaluation and implementation of changes related to assigned materials.
• Oversight of incoming testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance.
• Review and approve of production, QC, and AS&T records.
• Support exception investigations.
• Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Support OpEx improvement projects.

Kenntnisse

Collaboration

Communication

Continuous Improvement

Data Integrity

Decision Making

GMP

Leadership

Managing Ambiguity

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

Quality Inspections

Quality Management Systems

Regulatory Compliance

SPC

Supplier Quality Management

Ausbildung

Bachelor's degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent

Jobbeschreibung

Salary Range: €66,918.00 - €105,200.00

Job Description Summary

#LiHybrid

Location: Schaftenau.

As part of our team, you will be supporting introduction of new autoinjector devices to commercial phase and manage the primary packaging and/or device suppliers from a quality point of view.

You will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreements, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Job Description

Major accountabilities:

• Responsible for third party management of device component and primary packaging material suppliers.
• Responsible for evaluation and implementation of changes related to assigned materials.
• Oversight of incoming testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance.
• Review and approve of production, QC, and AS&T records.
• Support exception investigations.
• Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Support OpEx improvement projects.

Essential Requirements:

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• At least 3 years or more experience in MS&T, QC, QA or medical device industry.
• Experience in relevant operations or third party management.
• Fluent knowledge of English language (written and spoken).
• Flexibility to work in a fast paced, quickly changing work environment.

Desirable requirements:

• Experience in negotiations and global collaboration.
• Fluent in German.

Rewards

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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 € 65,605.54/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph:

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

Skills Desired

Collaboration, Communication, Continuous Improvement, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Leadership, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Inspections, Quality Management Systems (QMS), Regulatory Compliance, Statistical Process Control (SPC), Supplier Quality Management