Senior Manager Quality Assurance

Emmes Group

8 - 12 years

9 - 14 Lacs

bengaluru

Posted:1 hour ago| Platform:

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Skills Required

innovation qa management regulatory documentation document control process improvement auditing audit report internal audit assurance quality management partnerships clinical research qms quality assurance clinical trials inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manages the quality support for computer system validation activities for Emmes proprietary, Veridix AI, and commercial off-the-shelf (COTS) software systems used in clinical trials
Leads review and audits of computer systems verification and validation processes to identify potential gaps and non-compliance
Ensures the review of validation documentation for computerized systems and applications
Manages deviations and CAPAs related to computerized systems Manages one of multiple components of Emmes Quality Management System (e
g, internal auditing program, document control, CAPA program, etc
) Supervises QA Department staff Drafts and reviews QA policies and procedures Reviews and approves audit reports Creates audit schedules
Analyzes quality data for improvements in the QMS Leads process improvement activities Leads client audits and regulatory inspections
Prepares reports for QA management and internal leaders Provides corporate training and guidance as needed Other duties as assigned 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

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