Aseptic Processing Professional

Description

• Provide project management support on compliance related activities and continuous improvement projects specific to Filling, with the aim to close gaps within the required timeframe and ensure minimal impact to production activities.
• Filling representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.
• Perform and/or participate in GQD gap analysis for the Filling Department.
• Implements Corrective and Preventative Actions established as Filling commitments in response to Internal/ Global or Regulatory Audits.
• Identify opportunities for alignment across the IO platforms or within Filling, applying LEAN methodologies.
• Coordinate the media (broth) simulation operation: by working with QOSA review broth protocols, communicate and serve as liaison between the two departments; work with shift managers and filling group leaders to ensure successful completion of the media simulation study.
• Support the Environmental Monitoring (EM) program: coordinate policy and SOP updates and implementation; provide and conduct staff training; conduct weekly FMS review.
• Serve as coordinator with other service provider departments, such as, Metrology, Facilities, External vendors, etc., and support the shift managers with operational activities (ex. Annual instrument calibration, etc.).
• Assist in routine revalidation/non-routine validation activities such as autoclave revalidation, smoke studies, ISO Re-Certification etc. with QOVS, Thermal, QOSA. Review and approve related protocols.
• EM FFaST Lead: Conduct monthly discussion forum for EM Trends, EM Deviations, improvements that can help improve EM trends in controlled areas. Review and approve EM trend reports. Coordinate with QOSA to implement CAPA and GQD updates to area specific tasks.
• Develop training plan and maintain training database for new and existing employees to ensure all operators are qualified for required job tasks.
• Hold training sessions to ensure operators understand changes to existing procedures as well as the implementation of new procedures, and to field clarifying questions or concerns from staff.
• Role of system administrator for various production stand-alone equipment.

Qualifications

• Bachelor’s degree in Science / Engineering or in a related field with 1 -3 years of experience.
• Efficiently use company tools such as SAP, QualiPSO, Pharmnet Web, MASTER, Phenix, RapidPharma, Procal, Regulus etc., and the ability to adapt to new tools
• Strong interpersonal skills.
• Strong verbal and written communication skills