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AM/Dy. Manager - Quality Assurance - Zuventus Healthcare Ltd-Sikkim

AM/Dy. Manager - Quality Assurance - Zuventus Healthcare Ltd-Sikkim

Zuventus Healthcare

12 - 15 years

|

12 - 15 Lacs

Posted:Just now| Platform:

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Skills Required

pharmaceutical quality audit quality monitoring quality compliance quality management qms implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Overall responsible for QA activities.
Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments.
To review and Approval / Reject the Quality Management System documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, market complaints, product recall etc.
To review and approve risk assessments.
To perform self-inspection.
To review and approved /Reject QMS documents.
To prepare, review and approve the apex documents such as Site Master File, Validation Master plan and Departmental manual.
Release of finished product to market.

Preferred candidate profile

Having around 15 years of experience in QA in OSD.
Having audit exposure of PIC/S, EU GMP.
Having exposure of handling team.
Age between 35 - 40 yrs

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Zuventus Healthcare

Pharmaceuticals

Pune

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