Parexel FSP is looking for a Quality Training Specialist for a remote position in Brazil, Argentina, and Mexico!

Job Purpose:

Responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

Job Responsibilities:

Controlled Procedural Documentation Management Responsibilities

• Review Local Procedural Documentation
• Reviews global procedural documents to understand updates/changes
• Conducts central review of local procedural documents to determine if they are in compliance with the global procedure (impact analysis)
• Communicates with local procedural document authors to provide feedback on the central review outcome
• Documents outcome of central review

Periodic Procedural Document Assessment:

• Coordinates automated notifications to authors of impacted local procedural documents that periodic assessments are due
• Completes quality review of periodic assessments and communicates with local procedural document authors to provide feedback
• Tracks the status assessment completion to ensure implementation and compliance
• Issues escalation notifications to local authors who are non-compliant with periodic assessment requirements

Quality Control of procedural documents:

• Performs quality control checks for global procedural documents, by following internal processes and established standards within agreed timelines, including prioritizing multiple tasks for timely completion
• Performs quality control checks of information in the process management relational database.
• Acts as a subject matter expert for established documentation standards and internal processes for consistency and compliance within a controlled regulatory environment, including providing accurate guidance and information to global procedural document authors
• Supports documentation life cycle within the Global Document Management System (GDMS) and process management relational database to maintain a state of inspection readiness.
• Provides other documentation management support including, but not limited to GDMS searches, metrics, technology initiatives and process improvement projects

Process Management Relational Database:

• Adds data/information into the process management relational database (i.e., a database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal colleagues,
  auditors, vendors, and regulatory authority inspectors) by collaborating with the SOP authors
• Completes data quality checks, periodic and ad hoc reviews of the process management relational database content including follow-up on resolution of potential content discrepancies.
• Supports the following: running of departmental metrics and other reporting activities; provides advice on process enhancements and continuous improvement, support resolution any questions about or issues arising from the Process portal, partake in user acceptance testing of new versions of the
  underlying portal management software or resolution of technical issues.

Qualifications/Skills

• Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
• Minimum of a Bachelor’s degree or equivalent
• Demonstrated strong technical or digital skills in use of digital systems and new software
• Experience with design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical), or equivalent, such as experience of writing communications or training materials, intended for customers, or experience with process improvement projects and/or implementation of business process change management
• Experience of completing quality control review of pharmaceutical business process documentation (safety, regulatory, medical and/or clinical), or equivalent, such as quality control review of other types of documentation, training materials, presentations, communications or reports
• Experience of database maintenance, such as data entry, running reports and conducting data quality checks
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns