Job Description Ipqa/qms - Chennai, India - Levim Biotech

Levim Biotech

Verified Company

Chennai, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

JOB DESCRIPTION IPQA

Ensure compliance to cGMP for all operational activities.
Issuance and retrievals of Batch Manufacturing records
Review of the executed Batch Manufacturing records for compliance to the requirements.
Line clearance for product changeovers and packaging activities
Ensure the sampling of intermediate and finished product samples as per SOP and BMR
Verify environmental and personnel monitoring
To control the inventory of control samples.
To coordinate the Qualification / Validation of the Equipment, Systems and Process.
Planning routine activities in IPQA as well as timely ensure line clearance in the warehouse and production area.
Maintaining all observations & records of inprocess check to assure and increase the product quality.
Coordinate in the dispatch activities and maintain records
Daily rounds and monitoring of the shop floor (Production Warehouse and Engineering) activities to ensure the compliance with requirements

JOB DESCRIPTION QMS

To coordinate the Qualification / Validation of the Equipment, Systems and Process.
To ensure the Analytical method validation of cleaning process before conducting Cleaning validation.
Preparation of Cleaning Validation Master plan.
Preparation and Execution of Cleaning validation protocols.
Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation.
To conduct or organise revalidation activity at the defined frequency.
To conduct audits and periodic visit for contract manufacturing and testing organization.
Review & Investigation of quality complaints for products manufactured at contract manufacturing locations.
Involve in failure investigation of products manufactured at contract manufacturing sites and prepare reports accordingly.
Initiation and followup of market complaint CAPAs.
Review of Deviations and Change controls and to ensure closures.
Responsible for supporting contract manufacturing locations for effective implementation of Quality management system as applicable.
Supplier evaluation.
Responsible for identification, assessment and mitigation of risks within the Quality Operations.

Work Remotely

Salary:
From ₹11,500.00 per month

Benefits: