Manager - Quality Assurance (QMS)
2 weeks ago
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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