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Par Pharmaceutical
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Sr Associate - Compendial Review, Documentation

Sr Associate - Compendial Review, Documentation

Par Pharmaceutical

5 - 10 years

5 - 9 Lacs

Navi Mumbai

Posted:2 months ago| Platform:

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Skills Required

Standard Test Procedure pharmacopoeia QMS Documentation Global Test Specification Document Control ISO Guideline

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Posting Title Sr Compendial Review Associate Job Description Summary 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: - 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).

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Sr Associate - Compendial Review, Documentation