
Quality Analyst – Quality Management System
2 weeks ago
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, ₹22,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
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