QA Sterility Assurance Manager

As our QA Sterility Assurance Manager you will be the primary contact for sterility assurance, aseptic and bioburden controlled processes and environmental monitoring.
 
Key Responsibilities:

• Lead the Sterility Assurance team of 9, manage their work performance, define workload priorities, organize and control their activities
• Be the Single Point of Contact (SPOC) for any topic related to Sterility Assurance and Environmental Monitoring
• Escalate appropriately to site leadership team and Global Quality Assurance issues/risks associated with Sterility and Environmental Monitoring
• Maintain and ensure aseptic procedures are in place and in use
• Support investigations where aseptic assurance is at risk
• Oversight of microbial control strategy
• Establish and monitor Sterility Assurance and EM Key Performance Indicators
• Perform internal audits against cGMP rules, company policies and procedures, and the authority regulations concerning Sterility Assurance topics.
• Review and approve documents connected with Sterility Assurance topics

• University degree in pharmacy, microbiology, biology, chemistry, engineering or similar scientific field
• Minimum 5 years experience in Pharmaceutical industry with experience in aseptic production or sterile processes
• Experience with environmental monitoring, bioburden control and hygiene programs
• Strong English communication skills and proficiency in Hungarian
• Experience in deviation, investigation, CAPA and change control processes

• People management experience and a coaching leadership style
• Experience with electronic quality systems or digital tools for quality records
• Knowledge of data integrity principles and their application in quality systems
• Experience conducting internal audits and preparing for regulatory inspections
• Strong problem-solving and risk-based decision-making skills

• Hybrid working (2 days in HO per week) with flexible working hours
• Permanent contract
• Annual bonus and annual salary review
• Cafeteria (flexible benefits)
• Commuting support (company shuttle buses from Budapest and surrounding towns of Gödöllő, or fuel support if using your own car)
• Group life and accident insurance package
• Voluntary pension fund contribution
• Paid parental and caregiver leave
• Modern and clean working environment with an innovative culture