Sr Specialist

Responsibilities

• Participate in CSV activities for applications across multiple GxP business areas to ensure fit for use before release to production environment
• Participate in Qualification activities as it relates to infrastructure applications and hardware in a timely manner
• Be part of the team that conducts risk impact assessments to determine the extent of validation and qualification requirements
• Implementation of organizational IT controls in accordance with applicable regulations and internal procedures
• Author CSV deliverables including but not limited to Plans Summary Reports
• Support the SLC process as it relates to application validation and infrastructure qualification
• Identifies opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implement
• Supports inspections and audits (internal and external)
• Conducts periodic reviews to ensure applications remain in a state of compliance
• Participates and represents IT Validation Services in problem management and audit remediation activities
• Provides regular status updates to one up manager and escalates any potential issues in a timely manner
• Support CSV staff across defined GxP business unit applications to ensure fit for use before release to production environment

Qualifications / Experience

• B. E. / B. Tech. or equivalent in computer science, engineering, life science field
• A minimum of 7-9 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects
• Experience validating one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, Regulatory Submission systems
• General knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools
• Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM
• Familiarity with test automation tools desirable
• Good understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodology
• Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision
• Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth
• Excellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentations