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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 documentation
- Issuance, 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 training
- Preparation 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
What you need to know about the Kolkata Tech Scene
When considering the industries shaping India's tech scene, gaming might not immediately come to mind. However, in the last decade, increased internet usage and greater access to mobile devices have catapulted the industry to new heights, with Kolkata-based companies like Virtualinfocom, Red Apple Technologies and Digitoonz, at the forefront, driving the design and animation of new gaming titles for players.
