Deputy Manager, QMS

Actively Reviewing

Amneal Pharmaceuticals

India, Ahmedabad, Gujarat Full-Time Posted 3 months ago

Job Description

Job Description

Co-ordinating the Vendor Notification / Complaints / Quality Defect Reporting Systems, including but not limited to the initiation of Complaints /Quality Defect Reports (QDRs)/VNs, consulting with relevant parties, leading/ participating in investigations, liaising with departments, agreeing appropriate CAPA, tracking actions etc.
Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a supplier or other element of the role.
Reviewing / leading Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure any such investigations are documented appropriately with relevant CAPA, if necessary.
Co-ordinating local regulatory activities including update/ maintenance of the Site Master File, the company manufacturing authorizations, and other relevant documents.
Co-ordinating the Supplier Quality Management System, including reviewing supplier documentation, generating / reviewing Quality Agreements, co-ordination of the supplier /vendor notification system, conducting periodic reviews of suppliers etc.
Co-ordinating and supporting preparation for regulatory audits/visits including identifying FDA 483s, generating/ maintaining Audit readiness checklists/ plans / project charters as required by the Senior Manager Compliance /QP and any associated administrative work required, including generating / tracking readiness plans, reviewing regulatory updates/observations, etc.
Supporting the preparation (Redlining/Drafting /Formatting etc), review and approval of Quality System / Compliance documents as required for the Compliance Department. Documents include but are not limited to SOPs, Site Master File, Change Controls, Schedules, Product Specification Files, Deviations, Change Controls, CAPA, SOPs, Protocols, Reports etc.
Co-ordinating the company self-inspection system by maintaining databases, conducting trend analysis etc.
Carry out and assist in any training /ongoing training of new and existing personnel as appropriate. Generate training programs related to the job function as required etc.
General Administrative and other work for the Compliance Department
Any other duties assigned by Quality Management.

Qualifications

Minimum Bachelor's Degree in Pharmacy / Chemistry

Required Skills

Reporting Safety Root Cause Analysis Training SOPs Quality Management Trend analysis Risk Consulting Reporting Systems FDA Files Quality Leadership Vendor Defect reporting Formatting Quality Management System Investigations Supplier Drafting Supplier Quality Management Liaising