Quality Analyst – Quality Management System (QMS)

Job Title: Quality Analyst – Quality Management System (QMS)

Department: Quality Assurance / Quality Management

Location: Ameerpet

Reports To: Quality Manager / Head of Quality

Job Purpose:

To ensure compliance with regulatory standards, company policies, and quality management systems within the Clinical Research Organisation (CRO). The role involves monitoring, auditing, and supporting continuous improvement to maintain high-quality standards in clinical research activities.

Key Responsibilities:

*Implement and monitor Quality Management System (QMS) processes in accordance with ICH-GCP, CDSCO, USFDA, EMA, and other regulatory requirements.
*Conduct internal audits, vendor audits, and study-related audits to ensure compliance with SOPs and regulatory guidelines.
*Assist in preparation, review, and control of SOPs, CAPAs, deviations, and change controls.
*Support regulatory inspections and client audits by ensuring documentation readiness.
*Maintain training records and ensure compliance training for CRO staff.
*Identify process gaps and recommend corrective and preventive actions.
*Ensure proper documentation, record-keeping, and archival systems are followed.
*Collaborate with cross-functional teams (Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs).
*Drive continuous improvement initiatives to enhance CRO quality standards.

Required Qualifications:

Note: Only Males

Education: Pharm D (Doctor of Pharmacy) – mandatory.
Knowledge of Quality Management Systems, ICH-GCP, and global regulatory guidelines.
Familiarity with clinical research processes (clinical trials, pharmacovigilance, regulatory submissions).

Key Skills & Competencies:

*Strong knowledge of QMS principles and audit practices.
*Excellent documentation and analytical skills.
*Good communication and presentation abilities.
*Attention to detail with problem-solving mindset.
*Ability to manage multiple tasks under deadlines.

Experience:

*Fresher Pharm D candidates with strong knowledge of QMS can apply.
*Prior internship/experience in Quality Assurance, Clinical Research, or Pharmacovigilance will be an added advantage.

Employment Type: Full-time

Job Type: Full-time

Pay: ₹17,000.00 - ₹22,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person