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Introduction
If you are looking to build a strong career in clinical research and regulatory compliance, this opportunity could be the right fit. The Quality Assurance & Regulatory Affairs Job at Amaris Clinical offers professionals a chance to work in a structured and compliance-driven environment. With growing demand for skilled QA and RA professionals in India, this role provides exposure to industry-standard clinical practices and regulatory frameworks. Candidates with hands-on experience in clinical operations will find this opportunity especially valuable.
Job Overview
| Details | Information |
|---|---|
| Job Title | Quality Assurance – Regulatory Affairs / Senior Research Associate |
| Company Name | Amaris Clinical |
| Location | India |
| Employment Type | Full-Time |
| Department | Quality Assurance / Regulatory Affairs / Clinical Research |
| Experience Required | 2–5 Years |
| Education | B.Pharm / M.Pharm |
| Salary | ₹3.5 LPA – ₹7 LPA (Approx.) |
Company Overview
Amaris Clinical operates as a specialized clinical research unit under Caplin Point Laboratories. The organization focuses on delivering high-quality clinical trial services while maintaining strict adherence to global regulatory standards. With a strong emphasis on compliance, data integrity, and ethical research practices, Amaris Clinical has established itself as a reliable name in the clinical research sector in India.
Job Location & Employment Type
- Location: India
- Job Type: Full-Time
- Work Mode: On-site (as per clinical research requirements)
This role is ideal for candidates who prefer hands-on involvement in clinical trial operations and regulatory processes.
Open Positions / Department Details
The company is currently hiring for the following roles:
- Quality Assurance (QA)
- Regulatory Affairs (RA)
- Senior Research Associate
Number of Openings: 2 Positions
These roles are part of the clinical operations and regulatory compliance teams.
Key Roles & Responsibilities
Candidates selected for the Quality Assurance & Regulatory Affairs Job at Amaris Clinical will be responsible for a wide range of clinical and regulatory activities:
- Ensure compliance with GCP (Good Clinical Practice) and GLP (Good Laboratory Practice) guidelines
- Review clinical study protocols and Trial Master File (TMF) documentation
- Monitor and support clinical trial processes including:
- Subject screening and enrollment
- Dosing procedures
- Sample collection and processing
- Handle Investigational Product (IP) management and documentation
- Coordinate sample shipment and maintain proper records
- Review and update Standard Operating Procedures (SOPs)
- Manage equipment qualification, calibration, and maintenance documentation
- Ensure regulatory compliance across all clinical trial stages
- Support audits and inspections when required
- Maintain high-quality documentation and reporting standards
Eligibility Criteria
Education
- B.Pharm / M.Pharm from a recognized university
Experience
- Minimum: 2 years
- Maximum: 5 years
- Relevant experience in QA, RA, or clinical research preferred
Skills Required
- Strong understanding of GCP and GLP guidelines
- Knowledge of clinical trial processes
- Ability to manage multiple tasks efficiently
- Good documentation and analytical skills
- Team coordination and leadership abilities
- Attention to detail and compliance-focused mindset
Salary & Benefits
- Estimated Salary: ₹3.5 LPA – ₹7 LPA
- Salary may vary based on experience and expertise
Additional Benefits:
- Exposure to global regulatory standards
- Opportunity to work in a structured clinical environment
- Career growth in QA and regulatory domains
- Skill development in clinical trial management
Selection Process
The hiring process for this role typically includes:
- Resume shortlisting
- Technical interview (QA/RA knowledge)
- HR discussion
- Final selection
Candidates with strong clinical research experience will have an advantage.
How to Apply
Interested candidates can apply through email:
- Send your updated CV to: hr@amarisclinical.com
Important Tip:
Make sure your resume highlights:
- QA/RA experience
- Clinical trial exposure
- Knowledge of GCP/GLP guidelines
This will increase your chances of selection.
Important Dates
- Job Posted On: April 27, 2026
- No last date mentioned (Apply as early as possible)
Why Apply for This Job?
Choosing the Quality Assurance & Regulatory Affairs Job at Amaris Clinical can significantly boost your career in clinical research. Here’s why:
- Work with a reputed clinical research organization
- Gain hands-on experience in regulatory compliance
- Exposure to real-time clinical trial processes
- Opportunity to grow in QA and RA career paths
- Enhance your expertise in global clinical standards
This role is particularly beneficial for professionals aiming to transition into advanced clinical research or regulatory leadership positions.
FAQs
1. What is the required qualification for this job?
Candidates must have a B.Pharm or M.Pharm degree.
2. What experience is needed for Amaris Clinical hiring?
Applicants should have 2 to 5 years of relevant experience in QA, RA, or clinical research.
3. What is the salary for QA & RA roles at Amaris Clinical?
The estimated salary ranges from ₹3.5 LPA to ₹7 LPA depending on experience.
4. How can I apply for this job?
You can apply by sending your resume to hr@amarisclinical.com.
5. Is GCP/GLP knowledge mandatory?
Yes, understanding GCP and GLP guidelines is essential for this role.
Conclusion
The Quality Assurance & Regulatory Affairs Job at Amaris Clinical is a promising opportunity for professionals seeking growth in clinical research and compliance. With competitive salary packages, exposure to global standards, and a professional work environment, this role offers both learning and career advancement. Interested candidates should apply promptly to secure their chance.
Disclaimer
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