QC Reviewer
VitelyBio
Date: 4 days ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Summary
The QC Reviewer is responsible for ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. This role is critical in maintaining the integrity of research conducted within the organization, ensuring adherence to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines.
Key Responsibilities
The QC Reviewer is responsible for ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. This role is critical in maintaining the integrity of research conducted within the organization, ensuring adherence to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines.
Key Responsibilities
- Review raw data, study documentation, analytical reports, and other records to ensure accuracy and compliance with regulatory standards (FDA, EMA, ICH, etc.).
- Verify data integrity, consistency, and adherence to protocols, standard operating procedures (SOPs), and regulatory requirements.
- Ensure proper documentation practices (ALCOA+ principles) are followed in all QC-reviewed data.
- Identify discrepancies, deviations, and errors in reports and provide recommendations for corrective actions.
- Collaborate with laboratory analysts, study coordinators, and quality assurance teams to resolve issues related to data accuracy and compliance.
- Maintain proper documentation of QC reviews and findings, preparing detailed reports for management and regulatory bodies as required.
- Participate in audits (internal and external) and inspections by regulatory authorities.
- Provide training and mentorship to junior QC staff and other relevant team members on compliance and quality standards.
- Stay updated with regulatory changes and industry best practices to enhance the organization’s quality standards.
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- 2-6 years of experience in a Quality Control/Quality Assurance role within a Contract Research Organization (CRO), pharmaceutical, or biotech industry.
- Strong knowledge of GLP, GCP, FDA, EMA, and ICH guidelines.
- Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation.
- Excellent attention to detail and problem-solving skills.
- Strong communication and interpersonal skills to work effectively with cross-functional teams.
- Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) is preferred.
- Experience with bioanalytical, clinical, or preclinical study reviews.
- Knowledge of electronic data capture (EDC) and regulatory submission processes.
- Ability to handle multiple projects with tight deadlines while ensuring compliance and accuracy.
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