Qureos Mentor

FORWARD LIFE PVT.LTD

Job Title: Quality Analyst &ndash; Quality Management System (QMS)Department: Quality Assurance / Quality ManagementLocation: AmeerpetReports To: Quality Manager / Head of QualityJob 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 MalesEducation: Pharm D (Doctor of Pharmacy) &ndash; mandatory. Knowledge of Quality Management Systems, ICH-GCP, and global regulatory guidelines. Familiarity with clinical research processes (clinical trials, pharmacovigilance, regulatory submissions).Key Skills &amp; 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-timeJob Type: Full-timePay: &#8377;17,000.00 - &#8377;22,000.00 per monthBenefits:<ul><li>Health insurance</li><li>Provident Fund</li></ul>Work Location: In person

Quality Analyst – Quality Management System (QMS)

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FORWARD LIFE PVT.LTD

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Quality Analyst – Quality Management System (QMS)