Job Description

Job Title: Quality Associate- Quality Management System (QMS)

Department:

Quality Assurance / Quality Management

Employment Type:

Full-time

Location:

Ameerpet

Reports To:

Quality Manager / Head of Quality

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:

0-3 years in QMS/QA in clinical Research Industry Prior internship/experience in Quality Assurance, Clinical Research, or Pharmacovigilance will be an added advantage.

Important Notes (Mandatory Conditions):

Salary range is fixed - ?17,000 to ?22,000 (maximum) Working hours may extend by up to 1 hour based on business requirements Must be willing to work in rotational shifts if implemented in the future Should be willing to relocate to Hyderabad Commitment for 2 years is mandatory
Job Type: Full-time

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

Benefits:

Health insurance Provident Fund
Work Location: In person