DUTIES AND RESPONSIBILITIES:

Training and Documentation:

• Handle daily training and documentation tasks, ensuring compliance with GxP documentation and data integrity principles.

• As trainee SME, develop and evaluate training curricula, monitor training materials, and assess program effectiveness.

• Conduct training impact assessments and create Role Based Training matrices.

• Generate training metrics, create job aids/end- to-end workflows and conduct team trainings as required.

Content Management:

• Manage PD Electronic Document Management Systems (e.g., BMSDocs/Veeva) by creating, reviewing, and maintaining CSO-controlled documents.

• Oversee documents scheduled for periodic reviews and updates related to CAPAs.

Digital Solutions and SharePoint Management:

• Establish and manage a SharePoint site to enhance team communication and collaboration.

• Identify, implement and support digital solutions to replace paper-based processes or enhance existing processes.

• Evaluate and recommend electronic solutions to streamline workflows.

Quality and Compliance:

• Perform quality investigations, including root cause analysis, CAPAs and ensure timely completion of investigations.

• Ensure compliance with GxP documentation and data integrity principles in daily work.

Continuous Improvement:

• Identify opportunities for process optimization and implement best practices.

• Collaborate with cross-functional teams to drive continuous improvement initiatives.

• Monitor and analyze performance metrics to identify areas for improvement.

• Facilitate training sessions and workshops to promote a culture of continuous improvement.

Team Collaboration and Problem Solving:

• Address day-to-day challenges independently in a timely and professional manner.

• Collaborate effectively with team members to resolve routine issues.

• Exercise good judgment in identifying when to escalate technical or business challenges to upper management.

EDUCATION:

• Mandatory: Bachelor's degree in field of science

QUALIFICATIONS:

• Mandatory: Experience with Training Management systems/principles (e.g., SuccessFactors, ComplianceWire) and QMS Documentation Systems (e.g., EDMS, Veeva).

• Mandatory: Strong background in Good Manufacturing Practices (GMP) and GxP documentation, with familiarity with Data Integrity principles.

• Mandatory: Experience with Deviations/ CAPA metrics/generation and management 

• Experience in deviation writing, change controls, etc.

• Highly experienced in creating, managing, and maintaining SharePoint sites; experience with AI tools is a plus.

• Excellent attention to detail with the ability to work accurately and independently in a busy, demanding environment.

• Strong collaboration and communication skills.

• Ability to work within strict timelines, showcasing excellent organizational and time management skills.

• Ability to negotiate and act as a mediator between functional areas while meeting timelines and paying attention to details.

• Proficiency in Excel, Word, Visio, SharePoint, PowerPoint, etc.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities may be added based on business needs.

WORKING CONDITIONS:

• This role may involve working in an office, laboratory, or manufacturing area.

• Must be able to work in gowning attire within a controlled environment for extended periods.

• Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.

• Must be able to lift up to 15 pounds as needed.