What are the responsibilities and job description for the Change Control Specalist position at capgemini?
- Change Review:
- Review product and process changes to determine necessity and initiate the change control process.
- Changes may involve product design, formulation, manufacturing processes, or packaging.
- Change Control System Management:
- Oversee and manage the company's change control system, ensuring all changes are tracked, evaluated, and implemented systematically.
- Documentation:
- Thoroughly document changes, including rationale, risk assessments, potential impacts on product quality, and regulatory compliance.
- Change Tracking:
- Track and manage changes through initiation, approval, implementation, and closure stages to ensure compliance with internal and regulatory requirements.
- Impact Assessment:
- Assess potential impacts of proposed changes on product quality, patient safety, regulatory compliance, and related areas.
- Evaluate how changes might affect manufacturing processes, supply chains, or product performance.
- Cross-Department Collaboration:
- Work with Quality Assurance (QA), Regulatory Affairs, R&D, Manufacturing, and Supply Chain teams to evaluate the impacts of proposed changes.
- Change Control Documentation:
- Develop and maintain critical documents such as Change Control Forms, Risk Assessments, Impact Analysis Reports, and approval records.
- Stakeholder Communication:
- Keep stakeholders informed throughout the change control process, providing updates on status, risks, and issues.
- Closure and Archiving:
- Ensure successful implementation and verification of changes before closing the change control request.
- Archive all documentation in accordance with regulatory and company policies.
Qualifications
- Education:
- Bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or related discipline.
- Regulatory Knowledge:
- Strong understanding of standards like 21 CFR Part 820 (medical devices), 21 CFR Part 211 (pharmaceuticals), ISO 13485 (medical devices), ISO 9001 (quality management), and other applicable regulations.
- Knowledge of how product design, manufacturing processes, or packaging changes affect regulatory compliance and reporting.
- Experience and Skills:
- 3–7 years of quality or relevant process experience.
- Strong organizational skills to manage multiple concurrent changes, ensuring timely and compliant completion.
- Ability to lead and manage onshore and offshore teams.
- Capability to thrive in environments with conflicting priorities.
The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
Salary : $25 - $40
