Specialist, Change Control

2 weeks ago

Brampton, Ontario, Canada sun pharma Full time
Title: Specialist, Change Control (Contract)

Date: Nov 24, 2025

Location: Sun Pharma Canada Inc.

Company: Sun Pharma Canada Inc.

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

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