Research AssociateJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBResearch Associate
Cadila Pharmaceuticals Ltd
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Posted: 10 Apr 26
Job Description
Major purpose of the Job: To conduct Audit for BE Clinical, Clinical Trial, Medical Writing, Clinical Data Management, IT, Archival Department to ensure that activities are conduct as per applicable SOP
and Regulatory Requirements.
Responsibilities:
Maintaining Document control in CRO
-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.
Review of documents for BA-BE/CT department of CRO
-Online Audit for each phase of BA/BE studies.
-Clinical Trial site audit for ensuring trial related activities are conducted as per Protocol and
Approved Documents.
-Retrospective data review of BE Clinical and CT Department.
-Maintaining Document Control in CRO.
-To conduct system audit in BE Clinical and Clinical Research Department.
-Review of validation/ calibration & maintenance of equipment's 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.
-To conduct vendor qualification.
-Reviewing of SOPs, protocols, study plan and draft reports of respective department of CRO.
-Review of system audit trial for all instrument/ equipment's/ software of CRO.
Compliance:
-Ensuring BA/BE and CT studies are conducted in compliance with applicable regulations,
guidelines, and Standard Operating Procedures (SOPs).
-Interpreting and applying regulatory requirements to BA/BE and CT activities.
-Maintaining current knowledge of relevant regulations and guidelines.
Data Integrity:
-Monitoring compliance with data integrity principles (e.g., ALCOA++).
Communication and Collaboration:
-Communicating effectively with CRO staff, study directors/PIs, and other stakeholders on qualityrelated issues.
-Collaborating with other departments (e.g., laboratory operations, data management, clinical
operations).
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2871921
Job Category Sales and Marketing
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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