Research Associate - RQA

Job Title: Research Associate - RQA

Location: Dholka (Ahmedabad)

Salary: 3-4 LPA

Experience: 3-5 Yrs

Department: CRO-RQA

Job Description

• Issuing controlled/ documents, and other approved uncontrolled/usage copies of SOPs, forms/formats/logbooks, study documents of CRO.
• To check that correct documents are issued before issuing the same.
• To update and maintain the master document file.
• Issuing and compiling deviation forms and maintaining log.
• Issuing and compiling change control forms and maintaining log.
• To review data submitted by quality control department related to BA/BE study - Before study, during study and after completion of study.
• on-line phase monitoring of Bio-study
• To carry out system based audit of BA/BE/ CT and BA department at CRO.
• Verification of the files, logbooks, submitted for archival.
• Maintenance and updation of Quality Manual & CRO Master File.
• Review of validation/ calibration & maintenance of equipments and software.
• Handling of sponsor audit, queries resolution and response of sponsor queries & audit report.
• Ensuring updation of CRO procedure and SOPs according to current regulatory, guidelines.

Interested candidate can share there cvs at Shardulsinh.k@cadilapharma.com