Product Change Control Specialist

Job description:

Responsible for managing and overseeing changes in the product development, manufacturing, or distribution processes, ensuring that these changes are well-controlled and compliant with industry standards and regulations. This role is crucial in industries like pharmaceuticals, medical devices, food and beverages, and other regulated sectors, where any change in the product, process, or packaging could have significant impacts on product quality, safety, and regulatory compliance. The Product Change Control Specialist ensures that all product changes are systematically reviewed, evaluated, and implemented in a controlled manner, minimizing risks to product quality and ensuring compliance with regulatory requirements.

KEY RESPONSIBILITIES:

• Review Tobacco product and process changes to ensure they are necessary, and initiate the change control process when required. This could involve changes to the product design, formulation, manufacturing processes, or packaging.
• Oversee and manage the company’s change control system, ensuring that all product changes are tracked, evaluated, and implemented in a structured and controlled manner.
• Ensure that changes are documented thoroughly, including rationale, risk assessments, potential impact on product quality, and regulatory compliance
• Track and manage changes from initiation through approval, implementation, and closure, ensuring they meet all internal and regulatory requirements
• Assess the potential impact of proposed changes on Tobacco product quality, patient safety, regulatory compliance, and other key areas. This includes evaluating how changes may affect manufacturing processes, supply chains, or product performance
• Work with departments like Quality Assurance (QA), Regulatory Affairs, R&D, Manufacturing, and Supply Chain to evaluate the impact of the proposed changes on the product and its intended use
• Develop and maintain change control documents such as Change Control Forms, Risk Assessments, Impact Analysis Reports, and approval records.
• Keep stakeholders informed throughout the change control process, providing updates on the status of change requests and any risks or issues that arise.
• Once the change has been successfully implemented and verified, ensure that the change control request is closed and all documentation is archived as required

Required Skills:

• A bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.
• A strong understanding of regulatory standards such as 21 CFR Part 820 (medical devices), 21 CFR Part 211 (pharmaceuticals), ISO 13485 (medical devices), ISO 9001 (quality management), and other applicable standards
• Knowledge of how changes in Tobacco product design, manufacturing processes, or packaging affect regulatory compliance and reporting
• Strong organizational skills and the ability to manage multiple changes concurrently, ensuring that they are completed on time and within compliance.
• Quality / relevant process experience
• Ability to lead and manage a team
• Ability to succeed in environment with conflicting priorities

Life at Capgemini

Capgemini supports all aspects of your wegll-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.