IT Computer Systems Validation Analyst - Sotera Health Services LLC

IT Computer Systems Validation Analyst

Working in the regulated life sciences industry with GAMP5/21 CFR Part 11 and other global equivalent regulatory requirements, the Computer Systems Validation Analyst is responsible for supporting IT projects, service teams, and management in the quality aspects of implementation and maintenance of qualified/validated computer systems. In this role, the candidate will be responsible for participating in IT quality control activities such as,

• test plan development, risk assessments, evaluation testing, periodic reviews and execution of IT-related initiatives and activities.
• development and completion of IQ/OQ documentation for IT-related initiatives and activities.
• Development of Policies and Procedures.
• Interfacing with QA departments to clearly define the IT Computer Systems Validation and maintenance role and requirements in projects, initiatives, and operational activities.
• Facilitating periodic controls assurance activities, including but not limited to, periodic access reviews and system configuration and change management evidence collection.

Candidates must have experience working within a team environment, partnering with other business, quality and IT teams from various global regions, possess analytical and problem-solving skills, and have strong communication skills.

Under the guidance of IT Management, duties and responsibilities will include:

• Exemplify the Sotera Health standard of Safeguarding Global Health.
• Provide computer system validation/qualification and testing support.
• Shared responsibility in creating and executing test scripts, validations
• Shared responsibility in creating IQ/OQ documentation
• Ensure all inquiries requiring follow-up work and/or calls are resolved.
• Facilitate periodic controls assurance activities
• Liaise with QA teams to ensure alignment with the overall regulatory company compliance obligations
• Liaise with system and platform SMEs to ensure validation work plans and testing requirements are clearly defined.
• Provide expertise and guidance in interpreting governmental regulations, standards, and agency guidelines to assess the impact on IT Infrastructure to meet regulatory requirements.
• Support the development and maintenance of policies, processes, procedures, and other documents that are required in support of the compliance framework.
• Escalate to QA for approval in accordance with company procedures, e.g.: Approval of key documents, required retention periods for technical records, and critical changes.
• Participate in projects as appropriate, based on risk, to provide validation/qualification guidance.
• Participate in process reviews and support continuous improvement.
• Perform internal quality and compliance assessments of IT processes. Develop and maintain the assessment programs.
• Perform or participate in periodic assessments/reviews.
• Support audits of the IT Infrastructure, applications and services as required.

Required Skills and Experience:

• Degree in Computer Science or related field
• Minimum 3 years' experience working with Quality Management Systems or highly regulated industries where GAMP5, 21 CFR Part 11, or similar regulatory standards are applied.
• Effective oral and written communication skills, as well as collaborative ability.
• Demonstrated critical, analytical, and troubleshooting skills.
• Proven ability to work independently or as part of a team.
• Effective time management skills, prioritization, and ability to meet deadlines.
• Strong interpersonal skills including the ability to communicate, influence, and work effectively with a wide range of people.
• Task ownership and ability to follow through to completion.
• Self-motivated, organized and detail-oriented.
• Flexibility to adapt to competing and/or changing demands.

Beneficial Skills and Experience

• Experience in developing and adhering to standard operating procedures.
• ALCOA+(+) Principles
• Electronic document management systems
• Demonstrated experience preparing for and/or participating in regulatory or customer quality audits.
• Experience in IT General Controls and Sarbanes Oxley regulations
• Project/Program Management Skills

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