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Makro Group
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Clinical Quality Assurance ( CQA ) - Associate

Clinical Quality Assurance ( CQA ) - Associate

Makro Group

2 - 3 years

2 - 4 Lacs

Hyderabad Madhapur

Posted:3 days ago| Platform:

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Skills Required

Audit QMS Clinical Quality Assurance Doc Change Control CAPA ICH-GCP regulatory documentation GCP SOPs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Associate - Clinical Quality Assurance (CQA)
Department: QA - MakroCare and DDiJob Roles and Responsibilities:Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations.Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed.Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads.Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements.Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures.Provide training to staff on ISO standards and local regulations when necessary.Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file.Update logs for change control, deviations, CAPAs, amendments, and NTFs.Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities.Requirements:Education: Bachelor's or Master's in Life Sciences (or related field).Experience: 2-3 years of experience in Clinical Quality Assurance or related roles.Familiarity with ISO regulations, ICH-GCP guidelines, and QMS.Experience in conducting internal audits and maintaining regulatory documentation.Note: Additional responsibilities may be assigned by the Head of Department (HOD).

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Makro Group

IT Services and IT Consulting

Princeton New Jersey

501-1000 Employees

54 Jobs

Key People

John Doe

CEO
Jane Smith

CFO
Emily Johnson

COO

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Clinical Quality Assurance ( CQA ) - Associate