Manager - Quality Assurance (QMS)

Dishman Carbogen Amcis

11 - 17 years

8 - 15 Lacs

ahmedabad

Posted:12 hours ago| Platform:

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Skills Required

qms api quality assurance capa quality system management usfda change control quality sop preparation quality systems qms implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

1.Role & responsibilities

Preparation and review of Standard Operating Procedures.
Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management.
To impart internal trainings to DCAL Employees.
Review of the Instrument qualifications and re-qualifications protocols of Quality control.
Preparation & review of quality risk assessment documents.
Review and approval of analytical data related to QA release.
Review & Approval of Specification STP, Raw data sheet etc.
To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline.
Internal Audit and External audit Compliance
To support RA for analytical assistance.
Review of working standard management and Stability studies.
Handling of customer complaint, OOS, OOT, Incidents, Deviation & CAPA .
Responsible and participation, review of OOS Investigation, Deviation, Complaint Investigation.
To carry out any job assigned by Immediate Supervisor/HOD based on training.
To maintain safety, health and environment norms and usage of personal protective equipment during work.

Preferred candidate profile

Should be from API Background

Must good in English Communication

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