Main Responsibilities

Certify finished products prior to release.
Ensure that all regulatory requirements for batch release and certification are met.
Perform the routine duties and responsibilities of the Qualified Person (QP) in accordance with applicable legislation and guidance.
Provide QA expertise and guidance to ensure that Quality processes operate in accordance with applicable standards and requirements.
Review and approve GMP documentation, including deviations, batch documentation and other relevant quality records, as required.
Participate as a member of the management team in the investigation and management of product recalls.
Identify opportunities for quality improvement and support their implementation in a compliant and controlled manner.
Ensure the timely review and approval of deviations and complaint investigations, as applicable.
Maintain and continuously develop knowledge of global GxP regulations and guidelines and apply this knowledge to quality-related decisions.
Complete all required cGMP/GDP, corporate and safety training in accordance with Xellia requirements.

What We Expect

University degree in Life Sciences; a degree in Pharmacy is preferred.
Minimum 5 years of relevant cGMP experience in the pharmaceutical industry.
Demonstrable experience working in Quality within the pharmaceutical industry.
Eligibility to act as a Qualified Person (QP) in Hungary, with demonstrable experience in the role.
Demonstrable experience and sound knowledge of GMP regulations, particularly in relation to sterile manufacturing.
Professional working proficiency in English.
Ability to interact effectively with employees and stakeholders at all levels and across a variety of functions and disciplines.
Demonstrated ability to make significant quality-related decisions.
Strong follow-up skills and attention to detail.
Technical Skills and Competencies
Practical experience in manufacturing within a regulated industry.
Excellent interpersonal and communication skills, with a strong ability to collaborate and work effectively in a team environment.
Adaptability and ability to operate effectively in a changing environment.
Strong documentation and record-keeping skills, with good technical writing abilities.
Working knowledge of standard computer applications, including word processing, spreadsheet and database software.
 

What We Offer
 

Competitive compensation and benefit package
Dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
Opportunity to learn and develop
Good team spirit and friendly colleagues
Stable international company background
Multinational working environment
Home office opportunity