If you’re an M.Pharm professional with strong expertise in clinical trial quality management systems (QMS), this opportunity at Intas Pharmaceuticals could be a strategic career move. The company is hiring experienced candidates for Clinical Monitoring (QMS) roles in Ahmedabad, focusing on risk-based monitoring, SOP implementation, and global clinical trial oversight.
This role is ideal for candidates with 5โ8 years of experience in clinical research, pharmacovigilance, or quality assurance who want to transition into high-impact clinical QMS operations.
Job Overview
- Company: Intas Pharmaceuticals
- Role: Clinical Monitoring (QMS)
- Location: Ahmedabad, Gujarat
- Experience: 5โ8 Years
- Salary: โน4โ8 LPA (Estimated)
- Qualification: M.Pharm
- Employment Type: Full-Time
Key Responsibilities
- Establish and manage Quality Management Systems (QMS) for clinical trials
- Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines
- Prepare, review, and implement SOPs related to clinical trial QMS
- Provide risk-based inputs for protocols, ICF (Informed Consent Forms), CRFs, and Investigator Brochures
- Conduct site feasibility assessments and participate in site selection
- Perform risk-based audits and monitoring for global Phase IโIV clinical trials
- Collaborate with CROs for clinical trial progress and quality discussions
- Conduct risk management, impact assessment, and CAPA (Corrective and Preventive Actions)
- Analyze complex clinical data with critical thinking and strong analytical skills
Required Qualifications & Skills
- M.Pharm in any specialization
- 5โ8 years of experience in clinical trial monitoring or QMS
- Strong knowledge of GCP guidelines and clinical trial regulations
- Experience in SOP development and implementation
- Hands-on experience with risk-based monitoring and audits
- Excellent analytical, documentation, and communication skills
- Ability to work independently and in cross-functional teams
Why Consider This Role?
- Opportunity to work on global clinical trials (Phase IโIV)
- Exposure to sponsor-side clinical quality management
- Hands-on involvement in regulatory compliance and risk management
- Career growth in clinical research and quality assurance domains
How to Apply
