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QA Sterility Assurance Manager

GSK
QA / Test Engineer • Lead • Vor Ort • Vollzeit • 📍 Budapest
📄 Originalanzeige ansehen (EN)

A QA Sterility Assurance Manager role at GSK's Gödöllő site, serving as the primary contact for sterility assurance, aseptic and bioburden-controlled processes, and environmental monitoring. The position leads a team of 9 and ensures aseptic procedures, microbial control strategy, and cGMP compliance.

Responsibilities

  • ▹Lead the Sterility Assurance team of 9 and manage their work performance and priorities
  • ▹Act as Single Point of Contact for Sterility Assurance and Environmental Monitoring topics
  • ▹Escalate sterility and EM issues/risks appropriately to site leadership and Global QA
  • ▹Maintain aseptic procedures and support investigations where aseptic assurance is at risk
  • ▹Oversee microbial control strategy and establish/monitor KPIs
  • ▹Perform internal audits against cGMP rules, company policies, and regulations
  • ▹Review and approve documents related to Sterility Assurance

Requirements

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

Nice to have

  • ▹People management experience and a coaching leadership style
  • ▹Experience with electronic quality systems or digital quality tools
  • ▹Knowledge of data integrity principles
  • ▹Experience conducting internal audits and preparing for regulatory inspections

Soft skills

Leadership and team managementProblem-solvingRisk-based decision-makingClear communication

What we offer

  • ▹Hybrid working (2 days in office) with flexible hours
  • ▹Permanent contract
  • ▹Annual bonus and salary review
  • ▹Cafeteria (flexible benefits)
  • ▹Commuting support (company shuttle or fuel support)
  • ▹Group life and accident insurance, voluntary pension fund contribution
  • ▹Paid parental and caregiver leave
Languages: angol, magyar
Education: Egyetemi diploma gyógyszerészet, mikrobiológia, biológia, kémia, mérnöki vagy hasonló tudományos területen