Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Cutting-edge Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives.

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

This posting is for an existing vacancy.

📌 Specialist, Change Control (Brampton)
🏢 SUN PHARMA
📍 Brampton