Job Title: Aseptic Lead
We are seeking an Aseptic Lead to join a leading Pharmaceutical company in Sligo. The successful candidate will develop and update site-specific procedures related to gowning, aseptic practices, and contamination control.
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.
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.