Preety Devi

• One month industrial training in Stores Management, Manufacturing Process, Quality Control, Quality Assurance, Research and Development

Hold strong working experience in handling below responsibilities:

• Document and Data Control

Maintain and update document registers and databases

Ensure timely distribution of documents, ensure compliance with document control procedure and standards

Document issuance such as Batch records, Loose formats, Specification, STP, etc

SOP distribution, retrieval & archival

Review and retrieval of Batch records as per SOP

Arrangement of batch records in Doc cell

Handling of documentation in EDCS

• Batch Release

To review all batch documentation and completeness according cGMP to ensure timely release of batches

Assist in resolving quality concerns related to batch records review and maintaining compliance to all quality requirements

Responsible for preparing batch release documents & final batch release in SAP

• APQR Preparation

Responsible for preparation of Annual Product Quality Review report for marketed products in accordance with the company

Responsible for extraction and data compilation of analytical, manufacturing (including QMS tools), stability, regulatory and product related evaluation such as validation