Manager / Sr. Manager - Quality Assurance

8 - 12 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Aizant Drug Research Solutions Pvt. Ltd.

time outline icon Hyderabad, Telangana, India

Posted on 25-10-2021

146 Views

1 Vacancy

Description

Ensuring GCP / GLP and SOP compliance.
Review/Approval of clinical study protocols/bio analytical method SOPs and their associated documents.
Timely review/approval of study / validation reports (includes clinical/bio analytical/PK & Stats).
To plan / conduct in-process and retrospective audits at different phases of the study (e.g., Clinical, bio analytical, PK & Statistics and Diagnostics) as applicable.
To plan / conduct periodic internal audits of other departments.
Review/approval of audit reports, receiving of the responses and verification & follow-up of the corrective/ preventive actions.
Issuance of audit certificates.
Review / investigation of Change control, Deviations, Incidents, Events, Note to Files.
To monitor and follow up the pending CA/PAs.
Review of instrument/equipment qualification documents, Calibration records.
Preparation, Review of QA and other departmental SOPs.
Training and evaluation of department personnel.
Coordinate and lead/support during the external audits by sponsor/regulatory authorities.
Coordinate and prepare to respond to the regulatory queries.
Any other work assigned by the Department head.