Jr. Analyst, Digital Quality and Data Integrity (DQDI), QA

Company: Validation & Engineering Group
Location: Cambridge
Posted on: May 11, 2022

Job Description:

Validation & Engineering Group USA is searching for a dynamic DQDI Analyst to join our growing QA team. The DQDI, QA Analyst will confidently manage and maintain an inspection ready GxP Computerized System Validation archive; ensuring all GxP Computerized System Validations (CSV) and supporting Standard Operating Procedures at client site are collected and archived in a manner the maintains its data integrity throughout the systems life cycles.

The Analyst will maintain the inventory of all CSV documentation, follow the True Copy verification process moving documentation from paper to digital platform, create appropriate metadata and ensure complete collection of all records for inspection readiness.

The Analyst will be expected to partner with site Business owners, IT and QA to perform this role.

Responsibilities (including, but are not limited to):

High attention to detail, excellent technical writing experience.

Creates, maintains, reviews and revises procedures that ensure GxP computer systems are maintained in a validated state and in a continual state of inspection readiness with regards to cGxP.

Collects and tracks validation deliverables and packages for GxP computer systems to ensure accessiblity throughout document life-cycle.

Maintains archive for compliance with company policies, procedures and government guidelines, directives and regulations.

Provides training on document management related topics.

Supports regulatory and audit inspections.

Creates and reviews routine metrics and facilitates development of appropriate action plans as well as communication with key stakeholders.

Perform other duties as required.

Skills and Qualifications:

2+ years of Computer System Validation experience in a GxP pharmaceutical environment.

Working knowledge of quality systems and regulatory requirements (21 CFR Part 11, Annex 11, etc.).

Data integrity guidance (e.g., FDA, MHRA, CFDA, etc.).

Knowledge of technical writing principles and quality systems.

Proficient in MS Word, Excel, Visio, Power Point and other applications.

Knowledge of Veeva products desired.

Strong written and verbal communication skills.

Ability to communicate and work independently with scientific/technical personnel.

Requirements:

Bachelors degree in IT, computer science, engineering, library science or related field

2+ years of MS Visio and PowerPoint

3+ years of MS Word and Excel

Experience in the pharmaceutical industry

Knowledge of Good Documentation Best Practices Competencies

Analytical thought leader with strong ability to analyze systems, data, and reports to identify creative solutions

Excellent written and verbal communication skills

Skilled presenter with ability to command the attention of an audience at all levels throughout an organization

Collaborative yet decisive leader with track record for creating agile solutions

Keywords: Validation & Engineering Group, Cambridge , Jr. Analyst, Digital Quality and Data Integrity (DQDI), QA, Professions , Cambridge, Massachusetts