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Lab Systems Validation Specialist
2 months ago
The selected candidate will be an integral part of the IT Computerized System Validation (CSV) Division, overseeing and executing GxP computerized system validation initiatives in alignment with cGMP, CFR Part, and Annex regulations.
This role is crucial in ensuring that GxP systems fulfill their intended purposes and adhere to relevant regulations, contemporary industry standards, and Katalyst HealthCares & Life Sciences' internal policies.
Key Responsibilities:
- Provide independent technical guidance and take responsibility for comprehensive computer system validation activities.
- Ensure adherence to quality and compliance as per established protocols and standards by applying analytical thinking to CSV tasks.
- Create, evaluate, and authorize foundational documents such as Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), and Standard Operating Procedures (SOPs) to support Computerized System Validation/Assurance efforts.
- Develop, review, and execute validation documentation (IQ, OQ, and PQ) for GxP systems from Quality Control Units.
- Establish, implement, and maintain controlled documents related to computer system validation to support the initiation, validation, operation, and maintenance of GxP systems.
- Assist with change controls, Corrective and Preventive Actions (CAPAs), deviations, and exceptions necessary for system validation.
- Support administrative and maintenance activities for Lab Systems.
- Drive continuous improvement initiatives by monitoring, tracking, and executing steady-state activities for Lab Systems.
- Conduct gap analyses and necessary remediation on existing computer systems to ensure compliance with relevant regulations.
- Collaborate with stakeholders and team members to make informed decisions regarding the optimal validation strategies for computer systems.
- Work closely with approved vendor personnel to coordinate validation efforts, including the review and approval of related validation deliverables.
- Regularly review and update department-specific SOPs to ensure they reflect the latest regulatory changes and industry best practices.
- Conduct system assessments based on version upgrades and ensure all required verification and validation efforts are executed.
- Facilitate risk assessments related to computer system validation, including system-level and requirement-level evaluations.
- Assist in the development of business process deliverables such as process flows, data flows, user procedures, work instructions, and forms for GxP computerized systems.
- Perform periodic system reviews to ensure systems maintain their validated status.
- Support regulatory inspections and internal audits, implementing corrective actions as necessary in CSV.
Qualifications:
Minimum Required:
Bachelor's degree in Engineering, Science, or a related technological field.
Preferred:
Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS).
Experience:
Minimum Required:
- At least six years of experience in the pharmaceutical industry with GMP exposure.
- Understanding of Life Cycle Validation phases and practical knowledge of computer system validation/computer software assurance requirements.
- Familiarity with validation of cGMP automation/computerized systems within FDA-regulated environments, with a strong grasp of industry standards and best practices for computer validation.
- Ability to effectively manage multiple projects and priorities.
- Strong written and verbal communication skills.
- Excellent time management and interpersonal skills.
- Ability to work effectively within teams amidst rapidly changing priorities.
- Demonstrated analytical and problem-solving skills.
Preferred:
Relevant validation experience with laboratory systems utilized in the pharmaceutical sector is advantageous.
Knowledge, Skills, and Abilities:
Minimum Required:
Proficiency in Risk Management Tools, MS Word, Excel, PowerPoint, Visio, Project, and Outlook.
Preferred:
Experience with TOC Analyzer, LCMS-Sciex, Novatek LIMS, and ValGenesis VLMS.
