Hiring Alert: Quality Control (QC) Officer – Clinical Research | Fresher

Jobs On The Way; Kolkata District; On-site; INR 450,000 - 600,000; Full time

Job summary

Indoriv Clinical in Kolkata, West Bengal, invites applications for a Quality Control (QC) Officer to help maintain high standards of clinical trial documentation, data accuracy, and regulatory compliance.

You will review trial documents, monitor protocol adherence, manage TMF/SMF, support audits, and drive CAPA initiatives, collaborating with CRAs and regulatory teams. Freshers with certification may be considered; a strong eye for detail and communication skills are essential.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Certification in Clinical Research (preferred but not mandatory).
• Knowledge of ICH-GCP guidelines.
• Understanding of regulatory requirements in clinical research.

Responsibilities

• Review and verify clinical trial documentation.
• Ensure compliance with regulatory guidelines including ICH-GCP.
• Support audit readiness and quality systems.
• Strengthen compliance frameworks across studies.
• Review and maintain TMF and SMF.
• Verify informed consent documentation and safety oversight.
• Support internal QC checks before monitoring visits.

Education

Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field

Job description

Are you passionate about quality, compliance, and clinical excellence? If you thrive on accuracy, documentation, and regulatory standards, this exciting opportunity in Clinical Research could be your next big career move!

A growing clinical research organization, Indoriv Clinical, is inviting applications for the position of Quality Control (QC) Officer at its Kolkata, West Bengal location. This role is ideal for detail-oriented candidates committed to maintaining the highest standards of clinical trial documentation and compliance.

Position: Quality Control (QC) Officer
Location: Kolkata, West Bengal
Industry: Clinical Research
Application Email: [e-mail]

About the Role

Clinical research plays a vital role in developing safe and effective treatments. Behind every successful clinical trial is a strong quality control process ensuring data accuracy, regulatory compliance, and patient safety.

As a QC Officer, you will:

• Review and verify clinical trial documentation
• Ensure compliance with regulatory guidelines including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP)
• Support audit readiness and quality systems
• Strengthen compliance frameworks across studies

If you are looking to build a long-term career in Clinical Quality Assurance (QA) and Quality Control (QC), this opportunity is worth exploring.

Key Responsibilities

1. Clinical Document Review

• Perform QC review of clinical trial documents, source data, and eCRFs
• Ensure data accuracy, consistency, and completeness
• Identify discrepancies and coordinate corrections

2. Protocol Compliance Monitoring

• Verify study conduct aligns with approved protocols
• Ensure adherence to regulatory guidelines and internal SOPs
• Review deviations and assist with documentation corrections

3. TMF and SMF Review

• Review and maintain Trial Master File (TMF) and Site Master File (SMF)
• Ensure essential documents are properly filed and updated
• Prepare files for internal audits and sponsor inspections

4. Informed Consent & Safety Oversight

• Verify informed consent documentation
• Review safety reporting compliance
• Check Investigational Product (IP) accountability records

5. Pre-Audit Quality Checks

• Support internal QC checks before monitoring visits
• Assist in audit and inspection readiness
• Identify compliance risks proactively

6. RCA & CAPA Support

• Participate in Root Cause Analysis (RCA)
• Assist in implementing Corrective and Preventive Actions (CAPA)
• Track quality improvements across studies

7. Cross-Functional Collaboration

• Work with Clinical Research Associates (CRAs) and regulatory teams
• Resolve discrepancies efficiently
• Maintain high documentation and communication standards

Qualifications & Eligibility

Candidates should have:

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• Certification in Clinical Research (preferred but not mandatory)
• Knowledge of ICH-GCP guidelines
• Understanding of regulatory requirements in clinical research

Experience Preferred:

• Clinical trials
• Site operations
• QC or QA roles

Freshers with strong theoretical knowledge and certification may also be considered.

What Makes You a Great Fit?

Exceptional attention to detail
Strong documentation skills
Analytical thinking and problem-solving ability
Understanding of clinical trial workflows
Ability to work in a fast-paced research environment
Strong communication and coordination skills

If you naturally spot inconsistencies and believe quality is non-negotiable, this role is for you.

Career Growth in Clinical Quality Control

Quality Control is one of the most stable and high-growth domains in the clinical research industry. With increasing regulatory scrutiny and global clinical trials, skilled QC professionals are in high demand.

Career progression can include:

• Clinical Quality Assurance Executive
• Senior QC Officer
• Clinical Auditor
• Regulatory Affairs Specialist
• Clinical Operations Manager

Working in QC builds deep expertise in compliance, documentation systems, and regulatory frameworks — essential for leadership roles in clinical research.

Why Consider This Opportunity?

Join a growing Clinical Research Organization (CRO)
Gain exposure to regulatory audits and inspections
Strengthen expertise in ICH-GCP compliance
Build strong documentation and analytical skills
Establish a long-term career in Clinical QA/QC