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Engaged Employer

Meridian Enterprises

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3.7

based on 31 Reviews

4 Meridian Enterprises Jobs

Assistant QA Manager

Meridian Enterprises Pvt. Ltd.

3.7

based on 31 Reviews

8-12 years

Navsari

1 vacancy

Assistant QA Manager

Meridian Enterprises

posted 12d ago

Job Role Insights

Fixed timing

Key skills for the job

Analytical Chemistry Quality Inspection Investigations Compliance STP IPQA

+ 3 more

Job Description

To guide and train IPQA Persons to develop expertise, evaluate their skills and review training reports to ensure that they are well-prepared and qualified for their respective roles
To develop and implement a system for reporting IPQA persons
Lead the investigation of quality incidents, deviation, OOS/OOT and non-conformances
Ensure root cause analysis and implementation of corrective action and preventive action (CAPA) and monitor the effectiveness of CAPAs and report outcomes
To ensure that Batch record and batch analytical documents are filled online and reviewed before dispatch of products
To review and approve specifications and STP
To review / Approval / Control/monitor quality control-related activity and documents including SOP s, protocol and report
Prepare and maintain the facility for internal and external regulatory inspection and audits
Lead and participate in mock audits to identify and address potential compliance gaps
Collaborate with cross-functional teams to ensure adherence to QMS processes and provide support during regulatory inspections
Participate in quality improvement initiatives, identify opportunities to streamline processes and ensure the facility adopts best practices
To perform GMP round in all departments like production, QC, Micro, Warehouse, Engineering and report abnormal observation
To review the monthly report like stability study report, RD study report, FP retain sample report and hold time study report
If any abnormality observed in stability study report, RD study report, FP retain sample report carry out investigation and suggest suitable CAPA for the same