Company:
Katalyst Healthcares & Life Sciences
Location: South Plainfield
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Identify and troubleshoot operational issues and system issues.
Document business needs and identify solutions that align to overall business strategies. Review, analyse, and evaluate business systems for their applicability to identified user needs.
Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance.
Responsible for CSV documentation including System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (UAT), Traceability Matrix, Validation Summary Report, etc.
Support and maintain procedures and operational support processes.
Requirements:
Customer Service oriented with attention to detail and quality.
Reliable, consistent, proactive and accountable, adaptable to changes.
SaaS IT systems configuration or software quality assurance background.
Ability to effectively collaborate as part of a team yet can also work independently.
Problem solving skills.
Must be able to effectively prioritize and plan.
Strong communication and facilitation skills to develop consensus, clarity, and decision-making.
Understanding of technical IT issues to enable discussions with internal and external technical specialists.
Experience working in a GxP environment(s) is required, including change control, change management, CSV.
Experience with business process development and gap analysis, and business process mapping efforts.
Experience with Veeva Vault (RIM, Quality, and/or eCTD) is highly preferred.
Bachelor's degree in computer science, technology, operations, or related disciplines required.
5+ years in a pharmaceutical/biotech or related environment required.
Identify and troubleshoot operational issues and system issues.
Document business needs and identify solutions that align to overall business strategies. Review, analyse, and evaluate business systems for their applicability to identified user needs.
Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance.
Responsible for CSV documentation including System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (UAT), Traceability Matrix, Validation Summary Report, etc.
Support and maintain procedures and operational support processes.
Requirements:
Customer Service oriented with attention to detail and quality.
Reliable, consistent, proactive and accountable, adaptable to changes.
SaaS IT systems configuration or software quality assurance background.
Ability to effectively collaborate as part of a team yet can also work independently.
Problem solving skills.
Must be able to effectively prioritize and plan.
Strong communication and facilitation skills to develop consensus, clarity, and decision-making.
Understanding of technical IT issues to enable discussions with internal and external technical specialists.
Experience working in a GxP environment(s) is required, including change control, change management, CSV.
Experience with business process development and gap analysis, and business process mapping efforts.
Experience with Veeva Vault (RIM, Quality, and/or eCTD) is highly preferred.
Bachelor's degree in computer science, technology, operations, or related disciplines required.
5+ years in a pharmaceutical/biotech or related environment required.
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