Position:
Clinical Quality Assurance (QA) Auditor (Fresher)

Department: Quality Assurance

Location: Vadodara

Employment Type: Full Time

Qualification Requirement: M.Pharm or an equivalent qualification in a relevant scientific discipline.

Job Summary:

The Clinical QA Auditor (Fresher) will support the Quality Assurance department in maintaining compliance with applicable regulatory requirements, Good Clinical Practice (ICH-GCP), company SOPs, and quality management system (QMS) requirements. The role involves assisting in audits, document reviews, quality monitoring activities, CAPA tracking, and inspection readiness under the guidance of senior QA personnel.

Key Responsibilities:

Assist in planning and conducting internal quality audits of clinical research activities.
Participate in site, vendor, and document audits under supervision.
Participate in clinical study audits and review study documents for compliance with applicable SOPs, protocols, and regulatory requirements.
Assist in preparing audit agendas, checklists, audit reports, and follow-up documentation.




Support tracking and verification of CAPAs arising from audits and quality events.
Assist in maintaining Quality Management System (QMS) documentation, including SOPs, forms, logs, and records.
Support document control activities such as issuance, revision, archival, and retrieval.
Participate in quality improvement initiatives.
Assist in inspection readiness activities and preparation for sponsor and regulatory inspections.
Support qualification and monitoring of vendors and service providers.
Maintain audit schedules, quality metrics, and QA trackers.
Ensure adherence to ALCOA+ principles and data integrity requirements.
Participate in QA meetings, training programs, and continuous learning activities.
Perform other QA-related duties assigned by the reporting manager.

Preferred Skills:

Familiarity with Microsoft Office (Word, Excel, PowerPoint).
Positive written and verbal communication skills.
Str

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