Über die Tätigkeit
The Aseptic Process Validation Specialist is responsible for planning, executing, and overseeing aseptic process simulations (media fills) to ensure compliance with regulatory requirements and internal quality standards. The role involves coordinating cross-functional teams, documenting processes, analyzing results, and driving continuous improvement initiatives in aseptic operations.
Key Responsibilities
Process Simulation Execution:
•Plan, schedule, and execute aseptic process simulations (media fills) in accordance with regulatory guidelines (e.g., FDA, Boards of Pharmacy).
•Ensure the sterile environment and practices adhere to validated aseptic techniques.
Documentation and Reporting:
•Prepare and maintain comprehensive records of media fill protocols, results, and deviations.
•Generate and present reports summarizing APS findings, trends, and corrective actions to management.
Compliance and Quality Assurance:
•Ensure APS activities comply with cGMP, regulatory, and company standards.
•Act as a liaison during internal and external audits related to aseptic processing.
Team Coordination:
•Collaborate with production, quality, and validation teams to ensure readiness for APS activities.
•Train personnel on aseptic techniques and media fill protocols.
Continuous Improvement:
•Analyze APS outcomes to identify process gaps or improvement opportunities.
•Propose and implement corrective and preventive actions (CAPA) to enhance aseptic processes.
Risk Assessment and Troubleshooting:
•Perform risk assessments related to APS execution and aseptic processing.
•Troubleshoot issues encountered during simulations and ensure timely resolution.
Ihr Profil
Qualifications
Education: High School Diploma
Experience:
•3+ years of experience in aseptic manufacturing, quality assurance, or a related role within the pharmaceutical or biotechnology industry.
•Hands-on experience with media fills, aseptic techniques, and sterile production environments.
Skills:
•Strong knowledge of cGMP, FDA, and other relevant regulatory requirements.
•Excellent organizational and project management skills.
•Proficiency in data analysis and technical writing.
•Effective communication and interpersonal skills for cross-functional collaboration.
Working Conditions
•Work in cleanroom environments requiring adherence to strict gowning procedures.
•Ability to work flexible hours to accommodate media fill schedules.
Key Performance Indicators (KPIs)
•Timeliness and compliance of APS execution.
•Accuracy and completeness of APS documentation.
•Reduction in APS-related deviations and implementation of CAPA.
•Continuous improvement in aseptic process efficiency.
Unser Angebot
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.