Senior Computer Systems Validation Compliance Specialist
Welcome to 3M – a world-renowned company with a legacy of innovation and a commitment to making a real difference in people's lives. We are looking for a Senior Computer Systems Validation Compliance Specialist to join our team and help us ensure the quality and compliance of our computer systems. In this role, you will be responsible for designing, implementing, and maintaining validation processes for computer systems used in the development and manufacture of our products. We are seeking a highly skilled and experienced professional who is passionate about compliance and has a strong understanding of regulatory requirements in the medical device industry. If you have a proven track record of successfully leading computer systems validation projects and possess exceptional attention to detail, we want to hear from you. Join us in our mission to improve lives through science and technology.
- Develop and maintain validation processes for computer systems used in the development and manufacture of products, ensuring compliance with regulatory requirements.
- Lead and oversee computer systems validation projects, ensuring timely completion and adherence to all relevant guidelines and standards.
- Work closely with cross-functional teams to ensure that computer systems are properly validated and maintained throughout their lifecycle.
- Conduct risk assessments and develop strategies to mitigate any compliance risks related to computer systems.
- Stay up-to-date with industry regulations and guidelines related to computer systems validation and ensure that all systems are in compliance.
- Review and approve validation protocols and reports, ensuring accuracy and completeness.
- Train and mentor junior team members on computer systems validation processes and procedures.
- Collaborate with internal and external stakeholders to resolve any compliance issues related to computer systems.
- Participate in internal and external audits to ensure compliance with regulatory requirements.
- Develop and maintain documentation related to computer systems validation processes and procedures.
- Identify and implement process improvements to enhance the efficiency and effectiveness of computer systems validation.
- Serve as a subject matter expert on computer systems validation and compliance for the organization.
- Communicate effectively with all levels of the organization to ensure understanding and adherence to computer systems validation processes and procedures.
- Adhere to company policies and procedures, including safety and quality standards.
- Contribute to the overall success of the company by actively participating in team meetings and providing input on strategic initiatives.
Extensive Experience In Computer Systems Validation: The Ideal Candidate For This Role Should Have A Minimum Of 5 Years Of Experience In Computer Systems Validation, Preferably In A Regulated Industry Such As Pharmaceuticals Or Medical Devices.
In-Depth Knowledge Of Regulatory Requirements: The Senior Computer Systems Validation Compliance Specialist Should Have A Strong Understanding Of Regulatory Requirements Such As Fda 21 Cfr Part 11, Gamp 5, And Eu Annex 11. They Should Also Be Familiar With International Regulations Such As Ich Guidelines.
Ability To Develop And Execute Validation Plans: This Role Requires Someone Who Can Develop And Execute Validation Plans For Complex Computer Systems. The Candidate Should Have Experience With Validation Activities Such As Risk Assessments, Iq/Oq/Pq Testing, And Creating Validation Protocols And Reports.
Project Management Skills: As A Senior Computer Systems Validation Compliance Specialist, The Candidate Will Be Responsible For Managing Multiple Validation Projects Simultaneously. They Should Have Excellent Project Management Skills, Including The Ability To Prioritize Tasks, Manage Timelines, And Communicate Effectively With Different Stakeholders.
Strong Communication And Interpersonal Skills: This Role Involves Working Closely With Cross-Functional Teams, Including It, Quality, And Regulatory Departments. The Ideal Candidate Should Have Excellent Communication And Interpersonal Skills To Effectively Collaborate And Build Relationships With These Teams. They Should Also Have The Ability To Effectively Communicate Complex Technical Concepts To Non-Technical Stakeholders.
Risk Management
Quality Assurance
Project Management
Data Analysis
Change control
Regulatory compliance
Software testing
Documentation management
Audit Preparation
Validation Processes
Gxp Guidelines
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Computer Systems Validation Compliance Specialist is $90,000 to $130,000 per year. However, this can vary depending on factors such as location, experience, and company size. Some Senior Computer Systems Validation Compliance Specialists may earn higher salaries in the range of $150,000 to $200,000 with more experience and in high-demand industries.
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The 3M Company is an American multinational conglomerate corporation operating in the fields of industry, worker safety, US health care, and consumer goods.
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