Clinical Quality Assurance

5 days ago

Hyderabad Madhapur Telangana, India Makrocare Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Associate - Clinical Quality Assurance (CQA)

Department: QA - MakroCare and DDi

Job 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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