Senior Specialist, IT Validation Services

Location

Secunderabad | India

Job description

Sr. Specialist Computer System Validation (CSV) efforts for systems and applications in the pharmaceutical GxP space.

Collaborate with cross functional and multi-location IT Delivery teams, business users and IT Quality staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies.

Evaluate, propose, and implement technology solutions that improve digitization, compliance, and productivity. Serve as a CSV subject-matter-expert in support of internal and external regulatory inspections. Collaborate with peers across BMS on procedures relating to quality and computer system validation.

Key Responsibilities

Functional and Technical

• 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

People Management:

• 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 5-7 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, eDC, 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 etc.
• 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

Job tags

Salary