Job Description

Overview:
Job Posting Title
India Remote/Ahmedabad/Bengaluru/New Delhi
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The QA Specialist assists the QA Department in maintaining the quality system via reviewing validation documentation for computerized systems and applications, conducting internal and vendor audits, supporting client audits and regulatory inspections, and supporting other activities such as quality incident and controlled document management. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements. Responsibilities:

• Assigned to support Emmes' proprietary, Veridix AI, and commercial off-the-shelf (COTS) software systems used in clinical trials.
• Review and audit computer systems verification and validation processes to identify potential gaps and non-compliance.
• Review validation documentation for computerized systems and applications.
• Conducts internal audits of projects, processes, clinical sites, and deliverables
• Reviews documentation for accuracy and compliance (e.g., training records, CAPAs, quality incidents, audit reports, computer system validation documentation, project documents, etc.)
• Reviews and tracks non-compliances, deviations, and CAPAs
• Supports or leads supplier/vendor qualification and evaluation
• Supports or leads client audits and regulatory inspections
• Leads or participates in process improvement projects
• Writes and reviews corporate SOPs and policies
• Conducts trainings as needed
• Other duties as assigned

Qualifications:

• Bachelor's degree in Life Sciences or a related scientific field
• Quality Certifications Preferred, g., CQA, RAC, RQAP
• At least one (1) year experience in a quality assurance role with experience working in a regulated environment (e.g., GXP, ISO)
• Knowledge of 21CFR Part 11/EU Annex 11, GAMP 5, and related industry standards required with familiarity with security regulations such as NIST SP 800-53 and FISMA preferred.

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Skills Required