Quantys Clinical Hiring Research Associate (Quality Control Reviewer) – Bioanalytical
Are you an experienced professional in bioanalytical quality control looking for a new opportunity? Quantys Clinical Private Limited is currently hiring for the position of Research Associate (Quality Control Reviewer) – Bioanalytical. This role is ideal for individuals with 2-5 years of experience in a Contract Research Organization (CRO) and qualifications in M.Sc, M.Pharm, or B.Pharm.
Company Overview
About Quantys Clinical:
Quantys Clinical Private Limited is a leading CRO dedicated to providing high-quality bioanalytical services. With a focus on innovation and compliance, Quantys Clinical offers an excellent work environment for professionals aiming to make a significant impact in the pharmaceutical industry.
Job Role and Responsibilities
Position: Research Associate (Quality Control Reviewer) – Bioanalytical
Qualifications: M.Sc, M.Pharm, B.Pharm
Experience: 2-5 Years in a CRO
Key Responsibilities:
- Review of data generated from Method development, Method validation and Subject Sample Analysis activities as per SOP and regulatory compliance.
- Review of Master calibration schedule of Instruments and Equipment’s and review of all calibration status and records (Internal and External)
- Verify the accountability and records of all working standards including controlled substances.
- Review of Method Validation Report and Bioanalytical study reports as per Regulatory submission requirement.
- Online review of raw data for completeness and accuracy of data generation, compilation and compliance to SOP/ protocol.
- Ensure that all audit trails are thoroughly reviewed and any discrepancies if found are immediately escalated to department head and reporting manager.
- Regular auditing of BA activities and prepare the compliance reports.
- Implement and follow line-clearance procedure for enabling systematic approach and ensure online completion of related documentation and ensure for Good Laboratory Practice (GLP) compliance & Good Documentation Practices (GDP)
- Assist the reporting manager in on-boarding new employees by ensuring that the training requirements are identified and met.
- Keep track and send written reminders to analysts, system operators and group leaders on upcoming SOP revisions, scheduled calibrations, preventive maintenance and other time bound activities.
How to Apply
Interested candidates are encouraged to apply by sending their updated resume to hr@quantysclinical.com and info@quantysclinical.com.
