Review of draft and filled BMR
Review of final product COA and log sheet with chromatogram
Review and Approval of Product Quality Review (PQR).
Handling of Deviation, Change control, OOS, Investigation and Incident.
Preparation of SOP.
Review of Performance Trial Report
Preparation of Technical Package for customer filling.
Preparation of Validation Protocol and Reports
Update finished product check list.
Regulatory document support as per marketing requirements.
Preparation of Internal Audit Report and CAPA Report.
Review of Preventive Maintenance Schedule
Handling of Archival documents
To review of DQ, IQ, OQ, PQ protocol and approval of protocol.
To review validation protocol and reports.
Release the batch as per dispatch order and check the finish goods labels and other documents before dispatch.
To prepare quality management system documents as per requirements.
Fulfilling the customer & Regulatory Requirements.
To handle vendor qualification activity
Batch Release in absence of QA Manager
Annual Examination of retention sample.
Handling of sample activity for customer approval and maintain history
Internal compliance.
Customer Complaint investigation CAPA Compliance.
Get Daily compliance to procedures: on paper vs. practice
Ensure compliance of procedures and specifications are appropriate and followed.
Ensure that appropriate manufacturing in-process controls are implemented.
Ensure in-process controls are performed during manufacturing operations and results are satisfactory.
To conduct investigation conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.
To handle Retention sample management activity.
Gathering and Trending of quality related data & Data storage.
Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.
Online monitoring of Quality trend.
Review of Analytical documents.
Batch record Review
Maintain and tracking of the Corrective/Preventive Action system
Maintain & Monitor the safety practices in premises to achieve organization goal of Zero incident/Accident and document Related to Environment and Safety.
Abide to confidentiality policy of the organization.
Written communication with concern department.
In absence of IPQA person, Perform IPQA activity like BMR issuance, document Issuance etc.
Any other duty or responsibility as assigned by Head of Department from time to time.
Delegation and supervision of activities to subordinate.
Performing analysis of the finished product, raw material, packing material, in-process / Intermediate as per current STP.
Sampling of Raw Material / Packing Material / Finished Product.
Performing daily & Periodic Calibration of instruments as per current SOP.
Preparation & Standardization of volumetric solution / reagents.
Approve Laboratory material indents
Implementation of Good Laboratory practices to ensure the uniformity, consistency, reliability, reproducibility, quality, and data integrity of the analysis.
Review and investigate all laboratory data & Specification.
Ensure all Contract Laboratory have been qualified and adhere to qualification standards with cGLP.
Provide leadership, management, evaluation and training to all laboratory employees
Evaluate & Maintain the safety practices in laboratory to achieve organization goal of "Zero Incident".
Implement measures to protect against laboratory accidents include safety training and enforcement of laboratory safety policies, safety review of experimental designs and the use of personal protective equipment for particularly risky operations.
Review of KRA for QC Team.
Abide to confidentiality policy of the organization.
Any other duty or responsibility as assigned by head of department from time to time.
Initiation of Laboratory investigation during OOS & OOT.
Pay: ₹10,000.00 - ₹35,000.00 per month
Benefits:
- Leave encashment
- Provident Fund
Work Location: In person
