Job Title

FT Contract Role for a Sterility Assurance Expert in project managementPharmaceutical manufacturing / Aseptic processing7-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 involvedDesign and implementation of site Contamination Control Strategies (CCSs)Support for the definition of Sterility Assurance key aspects for new filling lines qualification:Decontamination treatmentsGloves managementAirflow visualization studiesCleanrooms qualificationDesign and evaluation of the Sterility Assurance risk-based strategies:environmental and utilities monitoring plans,cleaning & disinfectionaseptic techniquesinterventions managementfiltration and sterilization strategiesTraining, qualification and oversight of sterile department personnelDesign of Aseptic Process Simulation site strategies in compliance with the relevant regulatory standardDeliver high-quality documents aligned with international GMP requirementsAbout you:5-10 years of experience in the pharmaceutical manufacturing industry, with a specific focus on Sterility Assurance in aseptic processingDemonstrated 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 complianceProven strong knowledge of the Sterility Assurance related international regulatory standards and guidelinesGeneral knowledge of international compliance requirements, guidelines and standards related to Sterility AssuranceProfessional experience in leading teams in areas related to aseptic cleanrooms, process, equipment, consumables, aseptic behaviours and gowning and utilitiesMaster 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 teamsOutstanding planning and organizing skills to effectively manage multiple and complex projectsTo submit your application in strict confidence, click the ''apply'' button. If you require further information, please contact Voula Triantafillou on0437 853 201. #J-18808-Ljbffr