Sr. CSV Specialist
As our CSV Specialist, you will work in a fast-paced environment and play a crucial role in ensuring the development, implementation, validation, and qualification of all GxP systems and will be responsible for managing the Computer System Validation lifecycle, 21 CFR Part 11 and Data Integrity. You will lead and serve on cross-functional teams, assist IT with infrastructure and computerized compliance, and serve as the subject matter expert during audits and inspections.
- Review standard operating procedures (SOPs) and create a framework for the validation of the computer system.
- Review existing policies and develop and implement new policies and procedures to maximize both the quality and efficiency of information systems.
- Communicate with cross-functional teams to assist in the planning, development, installation, operation, validation, and qualification of information technology framework.
- Ensure adherence to SOPs, internal standards, and external regulations.
- Support open lines of communication across the organization, providing guidance, and implementing change to ensure computerized systems needs to meet high-quality standards.
- Execute documentation tasks to support the commissioning and qualification of GxP standards.
- Participate in both inspections and audits as a subject matter expert with excellent verbal, written, and interpersonal communication skills.
- Maintain the compliance of the validated system and IT processes. Identify risks and work with respective departments or IT team members on mitigation strategies.
- Assist in the planning, implementation, and management of computerized validation and quality systems.
- Support IT compliance requirements for infrastructure and computerized systems.
- Bachelors’ Degree in IT or related field
- Five years of experience validating systems and equipment
- Previous industry experience with server-based and cloud software
- Strong written and verbal communication
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.