- FT Contract Role for a Sterility Assurance Expert in project management
- Pharmaceutical manufacturing / Aseptic processing
- 7-month project (with potential to extend)
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries.
We are seeking a Sterility Assurance expert to work on a 7-month project, with a focus on aseptic processing and expertise in pharmaceutical project management.
You will be responsible for:
- Project management of Sterility Assurance projects, ensuring effective collaboration among the resources involved
- Design and implementation of site Contamination Control Strategies (CCSs)
- Support for the definition of Sterility Assurance key aspects for new filling lines qualification:
- Decontamination treatments
- Gloves management
- Airflow visualization studies
- Cleanrooms qualification
- Design and evaluation of the Sterility Assurance risk-based strategies:
- environmental and utilities monitoring plans,
- cleaning & disinfection
- aseptic techniques
- interventions management
- filtration and sterilization strategies
- Training, qualification and oversight of sterile department personnel
- Design of Aseptic Process Simulation site strategies in compliance with the relevant regulatory standard
- Deliver high-quality documents aligned with international GMP requirements
About you:
- 5-10 years of experience in the pharmaceutical manufacturing industry, with a specific focus on Sterility Assurance in aseptic processing
- Demonstrated strong technical knowledge in the areas of Sterility Assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance
- Proven strong knowledge of the Sterility Assurance related international regulatory standards and guidelines
- General knowledge of international compliance requirements, guidelines and standards related to Sterility Assurance
- Professional experience in leading teams in areas related to aseptic cleanrooms, process, equipment, consumables, aseptic behaviours and gowning and utilities
- Master experience in QRM principles application and main tools (Fe.g. MEA, HACCP, etc)
- Excellent leadership and interpersonal skills, showcasing your ability as team player and ability to manage cross-functional teams
- Outstanding planning and organizing skills to effectively manage multiple and complex projects
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.