Quality Auditor
Employer · TAPI
Field inspector
Quality inspector
Chemical engineerFull-timeDebrecen
The new employee plays a key role in maintaining and developing GMP compliance, ensuring that TAPI's corporate and site-specific quality requirements, as well as international and local regulatory standards, are fully met.
Tasks
- Participates in the development and prioritization of TAPI Hungary's GMP audit program.
- Conducts regular and targeted internal audits to evaluate compliance with local and corporate GMP regulations.
- Prepares audit reports summarizing observations, risks, trends, and necessary improvement measures.
- Monitors and evaluates the effectiveness of the implementation of corrective and preventive actions (CAPAs).
- Provides professional support to management on compliance and quality improvement issues.
- Conducts training sessions and knowledge-sharing programs to strengthen GMP compliance.
- Participates in the development of monitoring plans, audit methodologies, quality procedures, and performance indicators.
- Analyzes the results of audits and compliance reviews, identifying recurring issues and systemic risks.
- Participates in the development and review of quality management procedures and policies.
- Supports the preparation and execution of customer audits and regulatory inspections.
- Participates in the development of action plans and monitors their implementation.
- Supports the handling of complaints related to the activities of the Compliance team.
- Prepares regular reports and presentations for management.
Conditions & benefits
Professional developmentWe provide opportunities for continuous professional development and learning.Supportive communityYou will work with experienced experts in a supportive professional community.
Requirements
- Higher education in natural sciences (chemist, chemical engineer, bioengineer, or related field) or a pharmacy degree.
- Minimum 3 years of professional experience in the pharmaceutical or chemical industry in the following areas: quality assurance, quality control, manufacturing, technical field, research and development.
- Knowledge of GMP and confident familiarity with the pharmaceutical regulatory environment.
- Experience in quality assurance, quality management, or auditing.
- Fluent, active command of English in both spoken and written forms.
- Excellent communication and presentation skills.
- Strong problem-solving, analytical, and decision-making skills.
- Openness to teamwork and a collaborative mindset.
- Proficient MS Office skills.