Specialist in QA&QC department
Position: Specialist in QA&QC DepartmentLocation: BudapestCompany: A leading organization in the pharmaceutical industry, committed to quality and innovation.
Job Summary:
As a Specialist in the QA&QC department, you will play a crucial role in ensuring the quality and compliance of our products. You will be actively involved in qualification measurements, method development, validation, and various quality control tasks. Your expertise will contribute to maintaining high standards in our quality system and ensuring compliance with GMP and other regulations.
Key Responsibilities:
Actively participate in qualification measurements, including classical analytics and instrumental analytical measurements.
Develop, validate, and coordinate analytical methods.
Participate in the release of GMP and other raw materials.
Monitor and evaluate stability studies, and write reports.
Prepare documents related to quality control.
Ensure the proper functioning of the relevant part of the current quality system.
Comply with current SOPs, GMP, and other working regulations/guidelines.
Document deviations related to measurements, OOS/OOT results, and actively participate in quality checks.
Coordinate quality control tasks related to the production of clinical investigational products.
Compile the quality control part of the main file of documentation for clinical investigational products.
Participate in audits and official checks.
Issue quality certificates for supplied products and archive delivery documentation.
Ensure compliance with laboratory rules, fire protection, labor protection, and safety rules.
Requirements:
Excellent written and spoken English skills.
Professional higher education (MSc) in Chemistry, Chemical Engineering, or a related field.
Minimum 2 years of experience in the pharmaceutical industry/GMP.
Strong computer skills (MS Office).
Knowledge of relevant QA/QC principles.
Advantage: Knowledge of large-scale analytical instruments (GC, HPLC).
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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