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
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What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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