QC Reviewer VitelyBio
VitelyBio
Office Location
Full Time
Experience: 2 - 2 years required
Pay:
Salary Information not included
Type: Full Time
Location: Ahmedabad
Skills: Quality Control, Quality Assurance, Regulatory Guidelines, Documentation Practices, Communication skills, Interpersonal Skills, Microsoft Office, Project Management, Good Laboratory Practice GLP, Good Clinical Practice GCP, FDA Guidelines, EMA Guidelines, ICH Guidelines, Analytical data review, Problemsolving, Laboratory Information Management Systems LIMS, Bioanalytical Study Reviews, Clinical Study Reports Review, Preclinical Study Reviews, Electronic Data Capture EDC, Regulatory Submission Processes
About VitelyBio
Job Description
The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,