MAIN RESPONSIBILITIES

Participation related to regulatory inspections and corporate audits, including audit/inspection readiness, communications, response handling
Participation in local and global projects
Strong leadership skills: Lead the team, review and delegate the tasks, report the results to the manager.
Hold the team together and help them to improve and shine.
Creation of weekly and monthly reports about the organization performance.
Training of the team members and foster continuous improvement and develop solutions to address issues, improve processes and quality metrics.
Participation in prepariation work and review of the microbiological methods (routine /transfer).
Supervise & review of microbiological tests: (Total viable count: TVC, Specified Microorganism Test: SMT; Most Probable number: MPN, Bacterial Endotoxin test)
Reading and evaluating & reporting the results of microbiological tests
Drive projects to completion by proposing solutions, gathering feedback from stakeholders, identifying areas which need escalation and sharing lessons learned.
Write and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approval.
Escalate issues or potential Quality events in a timely manner.
Maintain and continuously develop knowledge of global GxP regulations and guidelines. This knowledge should be used to make quality decisions  (Ph. Eur, USP, JP).
Satisfactorily completes all cGMP corporate and safety training in conformance with Xellia  requirements.

QUALIFICATIONS

Education and Experience

BSc in relevant scientific field and a minimum of 3 years of cGMP experience
Minimum 3 years of experience participating member of a routine Pharma QC laboratory
Excellent written and oral communication skills both in English and Hungarian
Excellent analytical abilities and problem solving skills
Ability to provide leadership, set priorities and be accountable to timelines
Presentation skills to be able to represent the laboratory related topic for the higher management

Technical Skills Requirements

Experience in specifications and QC Bioburden and Sterility ,Endotoxina nd environmental monitoring methods in a regulated pharma industry
Excellent soft skills, including communication, teamwork and adaptability
Good record keeping skills and writing abilities
Working knowledge of various computer software such as word processing, spreadsheet, and database applications ( Myprocess)
 

Core Competencies

Functional/Technical Skills

Uses technical experience in order to deliver high quality solutions.

Seizes Accountability

Takes responsibility for own work and works diligently to meet deadlines.

Acts Decisively

Uses experience to make educated and timely decisions. A great deal of this contributors work may be done unsupervised, so he/she must be counted on to make informed decisions.

Change Agile

Maintains poise and accounts for changes in timelines and requirements; increases process and business foresight.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Weekend work required on occasion, dependent upon high priority project needs

Travel possibility in case of global projects.

What we offer:

Competitive compensation and benefit package
„Nordic-style” culture – 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

If you are interested please visit us at booth 16.