Specialist, Change ControlSun Pharma • Brampton, Peel Region, CA
Specialist, Change Control
Sun Pharma • Brampton, Peel Region, CA
30+ days ago
Job type
- Full-time
Job descriptionResponsible 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. 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. Ability to work under stressful conditions and prioritize workload. Numerous and varied responsibilities demanding attention and detail.
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
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
Working conditions
Physical requirements
Office based – 5 day on-site role.
Direct reports
NA
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Control Specialist • Brampton, Peel Region, CA
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