Loretta McIntosh

Working within various industries, I am able to work to an efficient level, whereby I am able to maintain excellent working standards. I have been working as an operator in highly regulated sterile environments over the last 18 months, whereby I would adhere to all aspects of aseptic behaviours and standard operating procedures that are set.

• Fully validated in all aspects of Checkweighing within a highly aseptic area, Grade A.
• Adhere to GMP Standards at all times.
• Competent batch documentation skills.
• Full aseptic licence and up to date with Standard Operating Procedures (SOPs), Risk Assessments and Policies and Procedures to ensure I stay compliant within the role.
• Validated in transferring components from non – aseptic areas, Grade C and D into aseptic/sterile Grade B and A areas via Hatch Transfers.
• Good time management and always strive to meet targets that are set.
• Attend and I am up to date with all training aspects which are required, including Aseptic Refresher Training, Operator Media Trial (OMT) and Process Stimulator Trial (PST Training). These are mandatory training modules and need to be completed annually.
• Validated and competent in undertaking aseptic cleaning of Laminar air flow (LAF) and unidirectional airflow (UDAF) in line with GMP.
• Validated and competent in undertaking aseptic cleaning of Grade A and B areas using a Sporicidal cleaning agent and technique to ensure the sterility of the area.
• Validated and competent in undertaking using a Sporicidal cleaning technique via hatch transfers of equipment, big or small. Following documented instructions from QA to take tryptic soy agar contact plates and swabs. To ensure the safety that no microorganisms are on the equipment which may compromise the sterility of the aseptic area.
• Undertaking environmental monitoring plates and ensuring the information labels contain correct information and incubate accordingly.

Aseptic Refresher Training – Annually 2024

OMT Training – Annually 2023

PST Training – Annually 2023

Extra training modules were on an ad-hoc basis, should there be changes to SOPs, new machinery introduced etc. These would be group based and would be mandatory for the teams to attend.