Quality Analyst – Quality Management System

1 day ago

Ameerpet Hyderabad Telangana, India FORWARD LIFE PVT Full time ₹ 2,64,000 per year

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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