Description
Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!We are seeking an experienced Computer System Validation (CSV) Specialist to support the validation of computer systems, including environmental monitoring equipment such as particle counters, and ensure compliance with regulatory requirements.
The CSV Specialist will be responsible for generating validation deliverables, supporting audits, driving change controls, and assisting in process improvement activities. This role requires in-depth knowledge of cGMP, regulatory standards, and quality systems to ensure robust testing and qualification of systems that are fit for use
Key Responsibilities:
- Technically support the implementation of particle counter instrumentation.
- Generate and review validation lifecycle documentation with the site CSV team, ensuring compliance with internal procedures and regulatory standards.
- Coordinate and monitor validation phases, providing regular project updates and ensuring timely execution of activities.
- Create and execute validation test scripts to ensure systems meet cGMP and regulatory requirements.
- Lead deviation review and change control processes to investigate issues related with validated systems ensuring compliance is maintained.
- Identify opportunities to streamline CSV activities, improving efficiency while maintaining compliance.
- Provide guidance on system upgrades and update operating procedures to meet regulatory requirements.
- Review CSV procedures, provide feedback, and participate in meetings to ensure documentation accuracy.
- Engage in the change control process, assessing changes to validated systems for regulatory compliance.
- Assist with audits, ensuring compliance and providing support for validated systems during internal and regulatory inspections.
Salary- Up to $60/hr
Requirements
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences, or related discipline).
- Proven experience driving Computerized Systems Validation efforts while establishing compliance for validation lifecycle documents in a highly regulated industry (e.g., pharmaceutical, life science, medical device).
- Hands-on experience with implementation of environmental monitoring equipment such as particle counters.In-depth understanding of cGMP, FDA, and other regulatory standards (IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11, etc).
- Experience in generating validation documentation (e.g., protocols, qualification reports) and performing change control activities.
- Ability to manage multiple projects and tasks simultaneously in a fast-paced environment.
- Experience with IT, Lab Instrument Validation, and Troubleshooting.
- Experience with Requirements Gathering, Deviations, and Root Cause Analysis.
- Experience with audits and supporting audit activities related to computer systems and validation.
- Strong problem-solving skills and ability to drive process improvements.
- Excellent communication and interpersonal skills to interact with cross-functional teams and management.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
