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:- Generate and review validation documentation with the site CSV team, ensuring compliance with internal procedures and regulatory standards.
- Identify opportunities to streamline CSV activities, improving efficiency while maintaining compliance
- 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.
- Assist with audits, ensuring compliance and providing support for validated systems during internal and regulatory inspections.
- Lead change control processes and investigate issues related to validated systems to ensure compliance is maintained.
- 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 quality.
- Engage in the change control process, assessing changes to validated systems for regulatory compliance.
Salary- Up to $65/hrRequirementsQualifications: - Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences, or related discipline).
- Proven experience in Computer System Validation and regulatory compliance in a highly regulated industry (e.g., pharmaceutical, healthcare).
- Experience with environmental monitoring equipment such as particle counters and other validation systems.
- In-depth understanding of cGMP, FDA, and other regulatory standards (HPRA, 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.
- Strong problem-solving skills and ability to drive process improvements.
- Excellent communication and interpersonal skills to interact with cross-functional teams and management.
- Experience with audits and supporting audit activities related to computer systems and validation.
BenefitsAzzur 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.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
