Computer Systems Validation (CSV) Specialist
⚡ Looking for expertise in CSV in regulated industries. Offering competitive benefits and a collaborative, growth-oriented work environment.
Company Overview
Welcome to NETSELF Inc., where innovation meets passion! We’re not just building a company; we’re creating a dynamic community that thrives on youthful energy, flexibility, and open-mindedness.
About Us: NETSELF Inc. is a young and ambitious venture, paving the way for a new era in the validation landscape through automation. We’re on a mission to reshape the future of validation and quality departments, and we’re just getting started.
Our Culture: At NETSELF Inc., we believe that creativity has no limits and that collaboration is its vehicle. Every idea has the potential to transform the industry. At NETSELF Inc., we’re not just offering jobs; we’re providing opportunities to shape the future of validation and quality management.
🌟 Why Join Us:
- Innovation First: We’re not afraid to push boundaries and embrace fresh ideas. Your creativity matters here.
- Flexibility: We understand that life is dynamic. Our flexible work environment supports your work-life balance.
- Open Collaboration: Your voice is heard, and your contributions make a real impact. We value open communication and teamwork.
- Premium Services: Join us in providing premium services that will redefine the standards of Validation, QC, and QA departments globally.
Ready to embark on a journey where your career is nurtured, and your potential is unleashed? Join NETSELF Inc., where the future of quality awaits your innovation.
Job Description
Responsibilities
- Implement NETSELF’s computer system validation (CSV) strategy, ensuring compliance with PIC/S Annex 11 and US-21 CFR part 11 requirements.
- Manage computer validation projects, enhancements, and requests for change (RFCs), change controls, investigations, and corrective and preventative action (CAPA) activities.
- Author and/or review validation documentation packages including CSV protocols and reports, standard operating procedures (SOPs), user requirement specifications (URS), functional and design specifications (FS/DS), traceability matrices, risk assessments, and others if applicable according to guidelines.
- Ensure controlled and/or regulated project documents and records are initiated, advanced, completed, and maintained following the clients’ Quality Management Systems (QMS) and relevant regulatory guidelines.
- Maintain Good Documentation Practices when completing GMP documents.
- Provide technical support and expertise to the end users and quality resources.
- Track/monitor and provide timely, accurate information regarding the status of tasks.
- Coordinate with other stakeholders and management to optimize validation processes.
- Maintain personal training file and assist in the training of other staff.
- Conduct QA audits of IT and validation processes as needed.
- Perform additional duties as assigned.
Qualifications:
- Experienced in the execution of CSV protocols for GxP-critical software and regulatory requirements.
- Strong analytical, problem-solving, and conceptual skills.
- Practical understanding of project management principles.
- Strong understanding of testing methodology and the software development lifecycle (SDLC).
- Ability to work well with cross-functional teams and diverse groups of stakeholders.
- Ability to work independently and flexibly and to adapt to changing priorities.
- Familiarity with automated enterprise testing tools is an asset.
- Effective written and oral communication skills.
Education and Training:
- Minimum of three years of hands-on experience in GxP-critical computerized systems validation per GAMP5.
- Experience in a pharmaceutical, biotech, or medical device environment.
- Degree or experience in STEM field.
- PMP certification is an asset.
Benefits Overview:
- Competitive pay and bonus structure.
- Bonus for healthcare coverage for the employees and their families.
- Retirement benefits.
- Generous paid time off.
- Comprehensive training and career planning.
Notes:
- Contract position.
- Managed travel is a requirement for this position.
- NETSELF Inc. supports flexible work environments, accommodating both in-office and home-based employees.
- It’s not necessary to meet every job requirement to apply; we review all applications thoroughly, considering diverse qualifications and experiences. Selecting the applicant that can provide the best value to the position and the clients.
Frequently Asked Questions
What Sets us apart?
At NETSELF, we think of employees as partners as they play a key role in our success with clients. That is why our culture mandates that we should share the revenue with them, and foster merit-based career growth without stiff outdated constraints, all while making sure that the company feels like their second home.
What kind of career development opportunities do we provide?
Be part of our developing team. We aspire to reshape the areas of validation, and quality in general. This means that we will have additional openings in the future to lead or take part in key projects and departments. Prove your worth and we will make sure you are in the best position for you and our business as well.
How do we support your work-life balance?
We value other aspects of your life and we know you have different priorities. with our flexible work hours, work-from-home policy, and paid time off, we hope you get quality time with your family and friends to be able to come to work fresh and lively every day.
Can I submit a general application if there are no current job openings?
Of course, we would like to get to know you! Also, we do have a record of submitted resumes. We may invite candidates from our talent pool. to positions that fit them in the future.