Specialist, Change Control

Job purpose

This role is responsible for the following:

• Change controls for the introduction of new materials supporting R&D and New Product Launches.
• Change controls for the introduction of alternative materials.
• Change controls for all types of change notifications from suppliers.
• Facilitation of the necessary communications.
• Execution of risk-based change impact assessments.

Duties and responsibilities

• Responsible for initiating change control for introduction of new materials, suppliers, vendors and distributors.
• Responsible for change controls for alternate source of materials such as excipients, APIs and packaging components.
• Create and drive to completion the change controls for all type of change notification from suppliers.
• Work with internal stakeholders on the necessary change impact assessments and actions.
• Establish strong working relationships with all necessary stakeholders.
• Assess if any follow up changes shall be triggered due to the proposed change and create appropriate tasks for their initiation.
• Ensure that the impact of the proposed changes are accurately interpreted into change control record.
• Monitor open change control proposals and close them in timely manner with completion of all tasks.
• Follow-up with stake holders on completion of the outstanding tasks before the due date.
• Create the proper change control extension request and execute it prior to the change record due date.
• Ensure continuous process improvement.
• Additional duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Minimum of 5 years of experience in quality systems.
• University or college degree in science or related field.
• Ability to work with little or no supervision and track multiple processes.
• Computer-savvy with a working knowledge & applications of Trackwise, SAP & MS office tools.
• Outstanding organizational and coordination abilities.
• Critical thinking and problem-solving abilities to ensure quality requirements are maintained while also meeting business expectations.
• Good collaboration and team work abilities.
• Ability to work in a fast-paced environment.
• Sound knowledge and application of Health Canada and FDA regulations.
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Process improvement mindset with ability to enhance productivity and reduce non-value-added work.
• Participation in investigations involving deviations to procedures or systems with logic, data and corrective measures.
• Experience in implementation of continuous improvement strategies towards enhancement of the quality standards of the department and facility.

Working conditions

• Ability to work under stressful conditions and prioritize workload.
• Numerous and varied responsibilities demanding attention and detail.

Physical requirements

Office based – 5 day on-site role.

Direct reports

NA