The pharmaceutical and clinical research industry continues to witness remarkable growth, creating exciting career opportunities for professionals passionate about quality, compliance, and patient safety. As clinical trials become increasingly complex, organizations are looking for skilled Quality Control (QC) professionals who can ensure that every process follows global regulatory standards while maintaining the highest level of documentation accuracy.
If you’re searching for Quality Control Executive jobs in Bengaluru, this latest opening at Samahitha could be the perfect opportunity to advance your career in clinical operations. The organization is currently hiring an experienced QC Executive to strengthen its quality management team and support ongoing clinical research activities.
Whether you are working in a Clinical Research Organization (CRO), pharmaceutical company, biotechnology firm, or healthcare research environment, this role offers an excellent platform to enhance your expertise in clinical quality assurance, audits, documentation, and regulatory compliance.
๐ข About Samahitha
Samahitha is recognized for its commitment to maintaining high-quality standards throughout the clinical research process. The organization focuses on ensuring that every clinical trial complies with national and international regulations while promoting continuous process improvement.
The Quality Control team plays a significant role in maintaining documentation integrity, supporting inspections, reviewing Standard Operating Procedures (SOPs), and ensuring operational excellence across multiple clinical studies.
Working with Samahitha provides exposure to modern clinical research practices while collaborating with experienced professionals in a quality-driven environment.
๐ผ Position Details
Job Title: Quality Control (QC) Executive
Department: Clinical Operations
Location: Bengaluru, Karnataka
Experience Required: Minimum 1 Year
Industry: Clinical Research / CRO / Pharmaceuticals
Employment Type: Full-Time
๐ Why This Opportunity Stands Out
Quality Control professionals are among the most valuable members of any clinical research organization. Their work directly impacts patient safety, regulatory compliance, inspection readiness, and the overall success of clinical trials.
This role goes far beyond simple document checking. It offers hands-on exposure to:
- Clinical Trial Audits
- Trial Master File (TMF) Reviews
- SOP Development
- Regulatory Compliance
- CAPA Management
- External Inspections
- Quality Systems Improvement
- Clinical Documentation Review
Professionals joining this role will develop expertise that opens doors to future careers in Quality Assurance (QA), Regulatory Affairs, Clinical Project Management, and Global Clinical Operations.
๐ Key Roles & Responsibilities
๐ Conduct Clinical Trial Audits
The QC Executive will prepare detailed audit plans and conduct quality audits across multiple clinical studies.
Responsibilities include:
- Site Audits
- Internal Process Audits
- Trial Master File (TMF) Audits
- System Audits
- Documentation Audits
The objective is to identify quality gaps early and ensure compliance with applicable regulations.
๐ Review Clinical Trial Documents
Documentation accuracy is essential for successful clinical research.
The selected candidate will review:
- Monitoring Visit Reports
- Clinical Study Protocols
- Investigator Brochures (IB)
- Informed Consent Forms (ICF)
- Informed Consent Documents (ICD)
- Clinical Study Reports
- Trial Documentation
Every document must align with sponsor requirements, study protocols, and regulatory guidelines.
๐ก๏ธ Support Regulatory Audits & Inspections
External inspections require extensive preparation.
The QC Executive will:
- Coordinate with auditors
- Provide requested documentation
- Participate during inspections
- Clarify quality procedures
- Assist inspection teams
- Prepare responses for audit findings
This role plays a major part in maintaining inspection readiness throughout the year.
โ๏ธ Manage CAPA Activities
Corrective and Preventive Actions (CAPA) are critical in quality management.
Responsibilities include:
- Identifying quality issues
- Investigating root causes
- Preparing CAPA plans
- Monitoring implementation
- Tracking effectiveness
- Preventing recurrence
Strong analytical skills are essential for this responsibility.
๐ Stay Updated with Regulatory Guidelines
Clinical research regulations evolve continuously.
The QC Executive must remain updated on:
- ICH-GCP Guidelines
- CDSCO Regulations
- FDA Guidelines
- Clinical Trial Rules
- Ethical Committee Requirements
- International Compliance Standards
Keeping track of regulatory updates helps ensure organizational compliance.
๐ SOP Management
One of the major responsibilities involves Standard Operating Procedure management.
Tasks include:
- Reviewing existing SOPs
- Updating outdated procedures
- Drafting new SOPs
- Evaluating functional feasibility
- Coordinating departmental reviews
- Maintaining SOP version control
Professionals interested in documentation management will find this role highly rewarding.
๐ Standard Forms (SF) Management
Apart from SOPs, the candidate will also manage Standard Forms (SFs).
Responsibilities include:
- Creating new Standard Forms
- Reviewing study-specific forms
- Maintaining master records
- Organizing documentation
- Tracking revisions
Accurate record management contributes significantly to operational efficiency.
๐ CEO Approval Workflow
Quality documents often require executive approval before implementation.
The QC Executive will coordinate the approval workflow by:
- Preparing documentation
- Tracking approvals
- Managing revisions
- Ensuring timely implementation
This responsibility provides excellent exposure to organizational quality systems.
๐ฏ Required Qualifications
Candidates should possess qualifications in any of the following disciplines:
- B.Pharm
- M.Pharm
- Life Sciences
- Biotechnology
- Clinical Research
- Biomedical Sciences
- Pharmacy
- Medical Sciences
Relevant educational backgrounds with clinical research exposure will be preferred.
๐ผ Experience Required
Applicants should have:
- Minimum 1 year of Quality Control experience
- Experience within Clinical Operations
- Experience in CRO or Pharmaceutical industry
- Knowledge of Clinical Trial documentation
- Hands-on exposure to audits
Candidates with practical audit experience will have an added advantage.
๐ง Required Skills
Ideal candidates should possess:
- Excellent attention to detail
- Strong documentation skills
- Audit planning knowledge
- SOP writing expertise
- Clinical Trial understanding
- Good communication skills
- Report writing abilities
- Regulatory knowledge
- Problem-solving mindset
- Time management skills
๐ Knowledge Areas
Successful applicants should understand:
- Good Clinical Practice (GCP)
- Clinical Trial Process
- Documentation Standards
- Quality Management Systems
- Risk Management
- Audit Procedures
- Clinical Compliance
- Data Integrity
- CAPA Process
๐ Career Growth Opportunities
Joining Samahitha can significantly strengthen your career profile.
Future career paths may include:
- Quality Assurance Executive
- Senior QC Executive
- Clinical Quality Specialist
- QA Lead
- Regulatory Affairs Associate
- Clinical Project Coordinator
- Clinical Operations Manager
- Global Quality Manager
Experience gained in audits and compliance is highly valued across the pharmaceutical industry.
๐ Why Work in Bengaluru?
Bengaluru has become India’s leading destination for biotechnology, pharmaceuticals, healthcare innovation, and clinical research.
Benefits of working in Bengaluru include:
- Large number of pharmaceutical companies
- Leading CROs
- Excellent career growth
- Better networking opportunities
- High demand for skilled professionals
- Competitive salary packages
- Exposure to global clinical trials
The city’s vibrant life sciences ecosystem makes it an ideal destination for professionals looking to build long-term careers.
๐ง How to Apply
Interested candidates should update their resume with relevant Quality Control, Clinical Operations, Audit, and SOP management experience before applying.
Email your updated resume to:
๐ฉ career@samahitha.com
Early applications are recommended as shortlisted candidates may be contacted on a rolling basis.
๐ก Tips Before Applying
To improve your chances of selection:
- Update your latest resume.
- Highlight clinical audit experience.
- Mention GCP training or certifications.
- Include SOP drafting or review experience.
- Showcase CAPA involvement.
- List TMF audit exposure.
- Keep your contact details updated.
โ Frequently Asked Questions (FAQs)
1. Who can apply for this Quality Control Executive role?
Candidates with at least one year of experience in Quality Control within Clinical Operations, CROs, or pharmaceutical companies are eligible.
2. Is this job suitable for freshers?
No. The role requires a minimum of one year of relevant Quality Control experience.
3. What educational qualifications are preferred?
Life Sciences, Pharmacy (B.Pharm/M.Pharm), Biotechnology, Clinical Research, and related medical disciplines.
4. What are the major responsibilities?
The role includes clinical audits, TMF reviews, SOP management, regulatory compliance, CAPA management, document review, and inspection support.
5. Where is the job located?
The position is based in Bengaluru, Karnataka.
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