Clinical Quality Assurance Associate Job in Hyderabad at Makro Group. Apply for CQA role with QMS, SOP and ICH-GCP knowledge in clinical research.
Candidates looking to build a career in clinical quality assurance and regulatory compliance have a strong opportunity with a reputed life sciences organization. This role focuses on Quality Management Systems (QMS), SOP management, and audit processes within clinical research. It is ideal for candidates who want to grow in quality assurance and compliance in a clinical research environment.
Company Overview
Makro Group is a global organization providing end-to-end solutions across the pharmaceutical and clinical research lifecycle. The company specializes in regulatory affairs, research analytics, and quality assurance services. With a multidisciplinary approach, Makro Group helps organizations meet regulatory requirements while maintaining high-quality standards.
Job Overview (Job Details)
| Category | Details |
|---|---|
| Organization | Makro Group |
| Role | Clinical Quality Assurance (CQA) – Associate |
| Qualification | Bachelor’s / Master’s in Life Sciences |
| Experience | 0–3 Years |
| Job Location | Hyderabad |
| Employment Type | Full-Time |
| Application Mode | Online |
| Salary | Not Disclosed |
Job Location & Employment Type
The role is based in Hyderabad and is a full-time position within the Quality Assurance function of the clinical research domain.
Open Positions / Department Details
The hiring is for the Clinical Quality Assurance (CQA) department. The role involves managing quality systems, documentation, audits, and compliance activities aligned with ISO standards and ICH-GCP guidelines.
Key Roles & Responsibilities
Candidates selected for this role will be responsible for:
- Maintaining, reviewing, and approving Standard Operating Procedures (SOPs)
- Preparing and managing Quality Management System (QMS) documentation
- Managing SOPs and training records in systems like mLMS
- Maintaining document repositories and archiving validation records
- Conducting internal audits of clinical research processes
- Ensuring compliance with ISO standards and ICH-GCP guidelines
- Managing change controls, deviations, CAPA, and amendments
- Updating logs and maintaining audit-ready documentation
- Preparing annual quality reports and trend analysis
- Supporting external audits from clients and regulatory authorities
- Providing training on quality standards and regulatory requirements
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Life Sciences or related field
Experience
- 0–3 years of experience in Clinical Quality Assurance or related roles
- Freshers with strong knowledge may also be considered
Skills Required
- Knowledge of Quality Management Systems (QMS)
- Understanding of ISO standards and ICH-GCP guidelines
- Experience in documentation and SOP management
- Familiarity with internal audits and regulatory compliance
- Strong analytical and organizational skills
- Good communication and teamwork abilities
Salary & Benefits
- Salary: Not disclosed (as per company standards)
- Opportunity to work in clinical research quality assurance
- Exposure to global regulatory standards and audits
- Career growth in QA and compliance roles
- Professional and collaborative work environment
Selection Process
The hiring process generally includes:
- Online Application
- Resume Screening
- Technical / Quality Systems Interview
- HR Discussion
- Final Selection
How to Apply
Interested candidates can apply through the official company career portal. Ensure your resume highlights your knowledge of QMS, SOPs, and regulatory compliance.
Important Dates
- Last Date to Apply: Not specified
Why Apply for This Pharma Job?
This role is an excellent entry point into clinical quality assurance, a highly important function in clinical research. Candidates will gain hands-on experience in audits, regulatory compliance, and quality systems.
With increasing regulatory requirements in clinical trials, professionals in CQA roles are in high demand. This position provides a strong foundation for long-term growth in quality assurance and regulatory domains.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any recruiter or company. We do not charge any fee for job applications. Candidates should verify all details independently before applying.
Final Call-to-Action
If you are interested in quality assurance and compliance in clinical research, this is a great opportunity to start or grow your career. Apply now and build your future in clinical quality assurance.
