We are currently seeking an Aseptic Lead to join a leading Pharmaceutical company in Sligo. The successful candidate will be responsible for developing and updating site-specific procedures related to gowning, aseptic practices, and contamination control. This individual will serve as an expert in sterility assurance, microbiological and environmental monitoring, and contamination control, with the opportunity to make a significant impact on the facility's growth.
Key Responsibilities:
- Develop and implement a comprehensive training and requalification program for isolator activities, gowning for Grade C and D areas, and aseptic behaviours.
- Contribute to the facility's sterility assurance program, ensuring that facility design, equipment, and processes meet aseptic requirements.
- Represent the site in aseptic governance for various projects, ensuring that aseptic processing, facility design, and sterile product filling meet regulatory and global standards.
- Oversee and provide support for sanitisation programs across the site.
- Assist with the environmental monitoring (EM) and utilities programs, as well as the aseptic and contamination control strategies in a multi-product facility.
- Stay informed about regulatory requirements and business processes related to maintaining sterile product standards, including facility design, cross-contamination controls, and data integrity.
- Review and update site procedures related to gowning, aseptic practices, and contamination control.
- Provide training in line with the site's sterility assurance program.
- Follow and ensure compliance with all Environmental, Health, and Safety (EHS) standards, procedures, and policies. Including reporting incidents and contributing to a culture of continuous improvement in EHS.
Qualifications:
- Bachelor's degree in the Science Field Is required.
- Minimum of 3 years' experience with aseptic and sterile processes, within in a GMP environment is required.
- Experience supporting regulatory inspections and familiarity with EU/FDA/ICH/HPRA and Annex 1 guidelines is advantageous.
