Digha, IND
176 days ago
Sr Compendial Review Associate
**Job Description Summary** • Performing identification of Pharmacopeial Updates and its review. Implementation of Pharmacopeial updates Globally through change management process. • Performing activity related to revision of product specification and method. • To support audit activity as per requirement. Incident & Change control review. CAPA implementation. • Review and implementing the common procedures as per department requirement. • Review of ISO Guideline update. **Job Description** Job Description: - + Identification, review and Implementation of Pharmacopeial updates Globally. + Performing activity related to revision of product specification and method through change management process. + Impact assessment of change. + Review of ISO Guideline update. + To coordinate with all interdepartmental activities pertaining to the USP/NF or other Pharmacopeial (if any) and ISO Guidelines. + Report works completion status to reporting manager. + Co-ordinate with Reporting manager for status update to the management. + Preparation of quality metrics, Risk Assessment related to Compendial Review Team + To perform the activity through QMS system compliance. + Preparation, Review and implementation of Common SOPs / Procedures / Policies. Education & Experience: - + M.Pharmacy/M.Sc + Minimum 6 To 8 yrs experience as QC/QC reviewer/QA (GMP). 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.
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