Sr Compendial Review Associate
Endo International
**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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