QA Job at MakroCare – Apply Now

ext-align: center;">QA Job at MakroCare – BSc & MSc Life Sciences Apply Now

Position: Quality Assurance (Clinical QA) – Associate

Location: Hyderabad, Telangana, India

About the Job

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 notes to file (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:

• 3-5 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).

Skills:

• ISO
• Quality assurance
• GCP
• ISO standards
• QMS

APPLY ONLINE HERE

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