Job Description
Join an international team improving healthcare futures, working in state-of-the-art facilities, with excellent career development opportunities and a patient-focused environment. Supervise a team of QA Manufacturing Analysts, completing activities in Environmental Monitoring, Personnel Qualification, Contamination Control and Clean Utility Sampling to support aseptic manufacturing operations. Responsible for communication, leadership and cross-functional updates, and monitoring QA Manufacturing Monitoring metrics and KPIs. Supervise a team of QA Manufacturing Analysts, train and develop team members, and ensure adherence to safety standards. Maintain current knowledge of regulatory and industry standards.
Key responsibilities include:
* Communication with Maintenance, Manufacturing, Quality Control and Validation Departments
* Supervision of QA Manufacturing Analyst team
* SME for Environmental Monitoring and Aseptic Monitoring activities
* Oversight of monitoring activities relating to Clean Utilities, Environmental Monitoring and Personnel Monitoring
* Qualification in gowning and participation in Aseptic Process Simulation monitoring intervention
* Support the training of team members
* Liaise with Equipment suppliers
* Ensure QA Manufacturing monitoring procedures are created/reviewed
* Participate in HACCP risk assessment
* Schedule sampling activities
* Perform trending of Environmental monitoring results
* Carry out technical review on data
* Lead investigation of sampling activities
* Participate in and responsible for QA Manufacturing Monitoring related CAPA’s
* Support the quality audit/inspection programmes
* Support the change control system
* Support projects and continuous improvement initiatives
Required skills and knowledge include:
* Knowledge of Aseptic Behaviors and sampling techniques
* Experience with investigating and determining root cause of Out of Specification/Out of Trend events
* Strong technical writing skills
* Excellent verbal and written communication skills
* Competence in Microsoft packages and SAP
* Project Management Skills
* Proficiency in communicating and collaborating at all organization levels
* Strong interpersonal skills
* Interpret and apply applicable regulatory guidelines
* Minimum 5 years QA/QC experience
* Bachelor's degree in Microbiology, Biochemistry or closely related scientific field
* Supervisory Experience in quality environment
* Experience leading and facilitating Quality Risk Management