Specialist, Change Control

SUN PHARMA; Brampton; Presencial; CAD 61.000 - 77.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus plan

Medical, dental and vision coverage

Life insurance

RRSP savings plan

Employee assistance program

Vacation and sick time

Descripción de la vacante

Sun Pharma is seeking a Quality Systems professional in Brampton, Canada, responsible for change control processes across suppliers, materials, and packaging. You will drive risk-based assessments and collaborate with internal stakeholders to ensure timely completion of change actions.

Qualifications include 5+ years in quality systems, a science degree, and proficiency with Trackwise, SAP, and MS Office. The role emphasizes regulatory knowledge and continuous process improvement in a fast-paced

Formación

• 5+ years of experience in quality systems.
• University or college degree in science or related field.
• Ability to work with little supervision and track multiple processes.
• Working knowledge of Trackwise, SAP & MS Office tools.
• Outstanding organizational and coordination abilities.
• Strong problem-solving and analytical skills.
• Team player with good collaboration abilities.
• Ability to work in a fast-paced environment.
• Knowledge of Health Canada and FDA regulations.
• Ability to influence others while maintaining integrity and trust.
• Excellent written communication and reporting skills.
• Experience with continuous improvement strategies.
• Experience investigating deviations to procedures or systems.

Responsabilidades

• Initiate change controls for introduction of new materials, suppliers, vendors and distributors.
• Manage change controls for alternate sources of materials (excipients, APIs, packaging).
• Create and drive change controls for all change notifications from suppliers.
• Work with internal stakeholders on change impact assessments and actions.
• Establish strong relationships with stakeholders.
• Ensure proper change control extensions prior to due date.
• Monitor open change control proposals and close them timely.
• Follow up with stakeholders on completion of tasks.

Conocimientos

Quality systems

Autonomy

Critical thinking

Problem solving

Collaboration

Fast-paced environment

Written communication

Influence others

Process improvement

Investigations

Continuous improvement

Quality regulations

Educación

Science degree

Herramientas

Trackwise

SAP

MS Office

Descripción del empleo

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 Innovative 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.

The presently-anticipated base compensation pay range for this position is $61,000 to $76,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company uses artificial intelligence to screen, assess or select applicants.