**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 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.