Quality Assurance

Job location: Ahmedabad

Experience Required- 4+ years of experience in QA (Clinical Research)

Role & responsibilities

A. Review Protocol and its attachments.

B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements.

C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements.

D. Conduct system audits as per the system audit plan.

E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan.

F. Preparation, Review, distribution, maintenance, recall and destruction of QMS Documents (SOPs, Policies, WIs, Manuals, forms and Plans . )

G. Review and maintain calibration, validation and Mapping documents and Temperature data / OOS data (Eurotherm data )review.

H. Issuance of logbooks.

I. Review of deviations, event and change control procedures and provide number to respective document.

J. Provide Instrument IDs as per SOP.

K. To maintain/update study/System specific tracker/Index on on-going basis.

L. Assisting Team in charge in Regulatory/Sponsor Audit.

M. Maintain Master Signature Log.