Aseptic Supervisor
McKesson
Toronto, ON
NATURE & SCOPE

The Sterile Compounding Supervisor is responsible for overseeing all aspects of sterile compounding of pharmaceutical products in accordance with the USP 797, NAPRA and documented guidelines set forth by the Advanced Care across all compounding facilities.

MAJOR ACCOUNTABILITIES

The Sterile Compounding Supervisor ensures that the following requirements are met:

A personnel training and assessment program is implemented at the facility. Personnel in charge of sterile compounding at the facility know and fully comply with policies and procedures for sterile compounding. Appropriate measures are in place at compounding facility to ensure the safety of personnel during each preparation. Policies and procedures covering all activities are developed, regularly updated and always followed at the compounding facility ( see USP 797 and Appendix 1 of NAPRA guidelines for compounding non-hazardous sterile products). Review the finished product sterility testing results and environmental monitoring results of ISO class 7 clean room in accordance with USP 71, USP 797, USP 800, and NAPRA at all compounding facilities. Ensure the facility and equipment used to compound sterile products meet requirements and are maintained, calibrated or certified according to specifications at compounding facility. Review the existing compounding process to certify that the process yields high-quality final preparations that are safe for patients. The available recognized scientific literature is used to determine stability and to establish the beyond-use date (BUD) for each sterile preparation compounded at compounding facility. A quality assurance program, designed to ensure that preparation activities are performed in accordance with standards of practice, scientific standards, existing data and relevant information, is implemented and followed in compounding facility. Mandatory and supplementary documentation is available and updated regularly in compounding facility (appendix 2 of the NAPRA guideline of compounding non-hazardous sterile products lists required publications and suggestions for supplementary documentation). All records required by the Model Standards are completed in compounding facility. Conduct scheduled and unscheduled compounding audits to ensure all the quality assurance programs outlined in appendix 12 of the NAPRA guideline are being followed in the compounding facility.

JOB PROFILE (Education & Experience)

(a)Education and job experience
Degree in Biology, Microbiology or Pharmacy or relevant field or equivalent work experience required
Or a Registered Pharmacy Technician with relevant sterile compounding qualifications
Strong knowledge of regulatory requirements governing the compounding of both sterile and non-sterile compounds

Specific skills

In depth knowledge of USP 797 and NAPRA for Sterile Preparations
Strong business acumen and ability to apply both tactical and strategic go to market models aimed at growing the customer base
Strong computer skills in a Windows environment using MS Office (Excel, Word)
Knowledge of pharmacy software
Highly organized with very strong attention to detail
Proven ability to manage time, set priorities and multi-task in order to meet various competing work deadlines
2-3 years of experience in the healthcare or pharmaceutical sterile compounding/manufacturing
Must be knowledgeable of quality control testing methods, validation techniques, physical testing methods/ concepts within an aseptic sterile compounding lab
Ability to work independently to plan, develop and coordinate sterile compounding activities across all compounding facilities
Ability to read, analyze and interpret complex topics using reasoning abilities to apply new sterile compounding concepts and draw valid conclusions.
Ability to work in a fast pace environment
Strong knowledge of government regulations impacting upon sterile compounding
This position requires a significant degree of precision and adherence to procedures and policies
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