Feladatok
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:
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
Elvárások
- 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
Előnyt jelent
- 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
Amit kínálunk
- 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
Munkahelyi extrák
- Canteen
- Cafe
- Medical assistance
- Corporate events
- Company bus
- Bicycle storage
- Parking
- Free fruits, snacks
- Free coffee, soft drinks
Hasonló állásokat kérek e-mailben
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