Quality Assurance Associate - Computer Quality Systems
Brampton, Ontario - Canada
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Employer Will Recruit From:
WHY IS THIS A GREAT OPPORTUNITY?
Our client in Brampton, On is actively looking for a qualified candidate to fill this 12 month contract position.
Responsible for providing Quality oversight of critical data systems for all company locations and major business partners.
Accountable for providing Quality oversight activities related to design, installation, qualification, maintenance of global automated systems such as LIMS, TrackWise, SAP, etc.
Proficiently provide guidance and support to the site Data Governance Officers for the purpose of overseeing the Site Data Governance Plans.
Responsible for performing oversight of the assessment of all systems (paper, hybrid or computerized) of the site level delivered by the site Data Governance Officers and Business Data Stewards. Oversight will ensure that the assessment performed was using a risk-based approach that corresponds with the risk of the system for data integrity throughout the data and product life cycles
Responsible for performing internal audits of Site Systems to ensure alignment with the requirements of the site and Global SOP’s and Policies.
Accountable for reporting on new compliance regulations from Regulatory authorities related to Data Integrity and Data Governance.
Proficiently act as the official designate for the Director, Corporate Quality, IT and Computerized Quality Systems.
Responsible for supporting the site Quality IT and computerized systems as needed. (*)
Accountable to support the site QA IT and Automated systems functions on an Ad Hoc basis. During these tasks, the reporting structure may change to the site Quality head.
Responsible for dealing with problems associated with a wide variety of data integrity or data governance challenges.
Accountable for problem solving associated with dealing with multiple departments simultaneously.
Minimum of B.Sc. Chemistry or other associated field.
At least 5 years at the supervisory/management experience (preferred).
Experience in pharmaceutical computerized systems.
Experience in data integrity and data governance (preferred).
Previous experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA).
Excellent written and verbal communication in combination with organizational skills and multi-tasking ability.
Knowledge of cGMP, FDA, HPFBI and associated guidelines related to Data Integrity and Data Governance.
Strong ability to effectively analyze problems, exercise sound judgement and make timely decisions.
Strong ability to influence without authority.
Excellent ability to extract information by questioning, active listening and interviewing to elicit and formally define requirements.
Demonstrated ability to work under pressure and manage conflicting priorities.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections**
University - Bachelor's Degree/3-4 Year Degree