Quantys Clinical Hiring Research Associate (Quality Control Reviewer) – Bioanalytical - PHARMA STUFF

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Sep 7, 2024

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.
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How to Apply

Interested candidates are encouraged to apply by sending their updated resume to sidhdharth.rajgor@quantysclinical.com / hr@quantysclinical.com and info@quantysclinical.com https://pharmastuff.org.in/job/quantys-clinical-hiring-research-associate-bioanalytical

 

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