Job Description Summary

We are seeking a meticulous and detail-oriented Documentation cum Analytical Specialist . This role involves managing documentation processes and performing analytical tasks to ensure compliance with industry regulations and maintain high-quality standards.

Job Description

QMS handling like change control, deviation, OOS, Investigation, CAPA, etc.,QMS trending.Handling site QA documentationIssuance, distribution and archival of documents.Document storage management.Handling compliance wire, document management system software, track wise, SAP etc.Collaboration with cross functional team.Providing trainingPreparation of SOP, protocol, reports etc.Knowledge in overall API QA function.Internal audit experience will be added advantage.Participated in USFDA regulatory inspection and arrange necessary documents as needed on timely manner.

Experience with electronic documentation management systems (EDMS).Familiarity with quality management systems (QMS).

Soft skill:

Good oral and written communication.Should be active and take own responsibilities.Collaboration with CFT.Meeting committed timeline.Good knowledge in computer operation and typewriting.

Others:

8 Years experience which should include min 5 years in QA