Senior Qa Compliance Specialist

Major Accountabilities

Accountable for investigating technical and mixed product complaints.

Accountable for the quality of the investigations.

Responsible for coordinating the actions of different departments to complete the investigations.

Responsible for prioritizing the workload to meet deadlines.

Support for the approval and closure of complaints.

Accountable for the sample management process.

Responsible for identifying improvement opportunities and support implementation.

Support the standardization of the complaint processes and the implementation of the process for new products.

Support the complaint team in preparing for internal/external audits.

Responsible for keeping complaint procedures and work instructions up-to-date with current regulation and global procedures/quality manuals.

Support the communication between complaints and key stakeholders.

Support in training new employees of the complaints team.

Support other functions as required.

Key Performance Indicators

Maintaining the Key Quality Indicators associated with the Complaints Department (on-time completion, effective CAPAs, extension rate, etc)..

Education

Degree in the natural sciences (pharmacy, chemistry, medicine, biology, microbiology).

Experience

Experience in the field of manufacturing medicinal products for human use; work experience in the field of GMP production/Quality Assurance or Quality Control; good knowledge of MS office applications and other standard IT applications. Must be capable of setting priorities and working under pressure. Ability to work well with internal and external participants is essential.

Language

Fluent in English and German ideally.

Impact on the organization

Ensuring the GMP guidelines in the assigned area of responsibility.

Specific Professional Competencies

Ease of use with office software. Structured work ethic. Goal oriented and transparent. Team player. Excellent communication skills across all levels in the organization. Can motivate colleagues to work towards common goals. Oriented towards problem-solving & logical thinking. Demonstrates high level of accountability and ownership.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards