Cyclotron Quality Lead, Lawson - London, Canada - St. Joseph's Health Care London

St. Joseph's Health Care London

Verified Company

London, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Posting # [ Non-Union ]

Cyclotron Quality Lead, Lawson

Lawson
St. Joseph's Hospital - London, ON
Temporary Full Time

Lawson Health Research Institute is one of Canada's largest and most respected hospitalbased research institutes. As the research institute of St. Joseph's Health Care, London and London Health Sciences Centre, and working in partnership with Western University, Lawson is committed to furthering scientific knowledge to advance health care around the world.
Lawson is seeking a Cyclotron Quality Lead for its Cyclotron & Radiochemistry Facility. Reporting to the facility Director, the successful applicant will be a key part of a large research/clinical team in a hospital environment.

Responsibilities:

Monitor QA functions related to the manufacturing, compounding, dispensing and quality control of radiopharmaceuticals in compliance to regulations, including GMP's
Review batch records and ensure that all necessary testing is carried out
Update facility Standard Operating Procedures (SOPs) as required
Maintain up to date Procedural Documents
Ensure SOPs are compliant with Health Canada and CNSC regulations
Approve or reject starting/raw materials, packaging materials, and intermediate, bulk and finished products.
Represent management during formal audits and perform informal audits to ensure compliance and to identify areas of improvement
Conduct quality control investigations when required and recommend corrective action. Monitor the implementation of corrective action.
Ensure required initial and continuing training of the department personnel is carried out and adapted according to need
Lead the interface with regulatory officials during inspectionsApprove specifications, sampling instructions, test methods and other Quality Control procedures
Responsible for auditing and qualifying vendors as per GMP requirements
Check the maintenance of premises and equipment
Maintain all validation protocol updates
Responsible to initiate product recalls including all other reportable occurrences to Health Canada

Other:

Complete other related duties that support the core activities of the Lawson Imaging Program
Due to the nature of the work, early morning shifts and occasional night coverage are required

Essential Qualifications

Master's degree in Chemistry
Minimum of 5 years of handson experience working with SOPs in a GMP environment within CNSC and Health Canada regulations
Knowledge of regulations, standards and guidelines relevant to radiopharmaceutical manufacturing
Working knowledge of radiopharmaceutical chemistry

Preferred Qualifications

Attention to detail with strong organizational and time management skills
Ablility to manage multiple activities, prioritize effectively, and meet tight deadlines
Strong leadership and problemsolving skills
Abillty to work independently and as an effective team member
Outstanding interpersonal and communication skills, both written and verbal

Immunization Requirements

Provide documentation you have received two doses of the COVID19 vaccine (primary series, boosters and/or XBB) OR one dose of XBB vaccine at least 14 days prior to the start date.
Provide vaccination records or proof of immunity against measles, mumps, rubella and varicella (chicken pox)
Provide documentation of the Tuberculosis skin testing

Posting date:
November 24, 2023

Submission deadline:
November 30, 2023

Jennifer Pasichnyk, Human Resources