Mikrobiológia Menedzser Budapest

Mikrobiológia Menedzser
Budapest
Budapest, Budapest

• Manage Quality Control (QC) activities related to regulatory inspections and corporate audits, including audit/inspection readiness, communications, and response handling 
• Review and approve API, FDF and IPC-related laboratory investigations, identifying root causes and developing appropriate CAPAs to prevent recurrence
• Adhere to the current EHS / KIR / MEBIR requirements and standards
• Ensure cGMP compliance and provide administrative and professional management of the QC Microbiological laboratories
• Ensure compliance with Hungarian and international pharmacopeias
• Foster continuous improvement and develop solutions to address issues, improve processes and quality metrics
• 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, and utilize this expertise to make quality decisions
• Foster Team Leaders, create positive atmosphere and build a good working culture. Manage 3 teams within a department of 20 employees
• Have a holistic overview about the QC activities and their impacts on the related different departments

• BSc or MSc in a relevant scientific field (preferably biology, bioengineering, microbiology, or food engineering)
• Minimum of 5 years of Pharma cGMP experience
• Minimum 3-5 years of leadership experience in a QC laboratory
• QC experience in a regulated industry
• Excellent written and oral communication skills
• Excellent analytical abilities and problem-solving skills
• Ability to provide leadership role modelling, set priorities, and be accountable to timelines
• Excellent soft skills, including communication, teamwork, and adaptability
• Fluent in Hungarian and English, both written and oral
• Good record-keeping skills and writing abilities
• Working knowledge of various computer software such as Labware LIMS and TrackWise 

• Competitive compensation and benefit package (including a company car and management health check-up)
• „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