QA Manager
Position: QA Manager
Location: Budapest
Company: A leading organization in the pharmaceutical industry, committed to quality and innovation.
Job Summary:
As a QA Manager, you will be responsible for ensuring compliance with various quality standards and regulations in the manufacturing and wholesale sector. You will organize and implement audits, maintain the documentation system, and support the continuous modernization of the quality assurance system. Your role will involve close cooperation with colleagues across departments and active promotion of digital transition.
As a QA Manager, you will be responsible for ensuring compliance with various quality standards and regulations in the manufacturing and wholesale sector. You will organize and implement audits, maintain the documentation system, and support the continuous modernization of the quality assurance system. Your role will involve close cooperation with colleagues across departments and active promotion of digital transition.
Key Responsibilities:
- Control compliance with GMP, GLP, GDP, ISO 9001, ISO 14001, ISO 17025, and ISO 13485 aspects in the manufacturing and wholesale sector, supporting operations accordingly.
- Ensure compliance with HACCP and hygiene requirements.
- Organize and implement external and internal audits, and accept customer inspections and audits.
- Maintain and operate the documentation system, support colleagues, and actively promote digital transition (including scanning, distribution, archiving, and disposal).
- Fully control documents related to the production and release of clinically investigated products.
- Fulfill ISO and GMP educational tasks.
- Continuously modernize the quality assurance system.
- Develop and automate administrative processes.
- Cooperate closely with colleagues in departments, conducting weekly checks.
- Stay updated with current guidelines (FDA, ICH, EMEA) and manage changes.
Requirements:
- 3-5 years of relevant work experience in a GMP, GLP, GDP environment.
- Higher education in natural sciences (chemist, pharmacist, chemical engineer, bioengineer).
- Accurate, result-oriented, and structured work approach.
- Confident oral and written English skills.
- Ability to work independently.
- Intermediate computer user skills.
- Responsibility, accuracy, and precision.
Preferred Qualifications:
- Participation in API registration.
- Participation in CAS number registration.
- Experience in compiling a monograph.
- Experience in the production of terminally sterilized products.
- Experience as a responsible person or a qualified person.
What We Offer:
- Competitive compensation and benefits package.
- Opportunity to work in a dynamic and innovative environment.
- Professional development and career growth opportunities.
- Supportive and collaborative team culture.
- Flexible working conditions, including the possibility of remote work.
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