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QC Jobs Life Sciences & Biotech at Samahitha Research
QC Jobs Life Sciences & Biotech are available for BSc candidates at Samahitha Research. This is your opportunity to work in Clinical operations at Bengaluru.
Job Title: Jr. Quality Control (QC)
Department: Clinical Operations
Company: Samahitha Research
Experience Required: Minimum 1 year in Quality Control
Location: Bengaluru, Karnataka
Salary Range: ₹22,000 – ₹25,000 per month
Job Description:
Samahitha Research is seeking a Junior Quality Control (QC) Executive to join our Clinical Operations team. The ideal candidate will support quality management activities and ensure compliance with regulatory requirements, sponsor guidelines, and internal quality standards for clinical trials.
Key Responsibilities:
• Prepare audit plans, conduct audits (site audits, TMF audits, and system audits), and generate comprehensive audit reports for all clinical trials conducted by Samahitha Research.
• Review monitoring reports, study protocols, informed consent forms, investigator brochures, and study reports (as per sponsor agreement and study management plan).
• Assist during external audits and inspections, liaise with external auditors/inspectors, and contribute to corrective and preventive action (CAPA) planning.
• Stay updated on national and international laws, regulations, and guidelines governing clinical trials.
• Review existing Standard Operating Procedures (SOPs), evaluate their feasibility, and recommend updates when necessary.
• Create or update SOPs related to the Quality Control function and obtain necessary approvals from the CEO.
• Develop, review, and maintain Samahitha Standard Forms (SFs), ensuring all documentation is current and properly archived.
• Maintain a comprehensive list of all active SOPs and SFs across departments.
• Review and ensure compliance of all study-specific customized forms.
Required Skills and Qualifications:
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Minimum 1 year of hands-on experience in Quality Control within Clinical Operations or a similar domain.
• Good understanding of GCP (Good Clinical Practice) guidelines and clinical research processes.
• Strong documentation, organizational, and analytical skills.
• Excellent communication and interpersonal abilities.
• Proficient in MS Office and documentation management tools.
