Division

Department

Sub Department 1

Job Purpose

Prepare, update and review the specifications, SOPs, policy and operating documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective standards / pharmacopeia and cGMP requirements

Key Accountabilities (1/6)

Prepare documents like SOPs, specifications and non-routine documentation and ensure timely availability across the site to provide support during the analysis

Prepare / revise corporate documents like SOPs, general analytical methods etc. by coordinating with site QC/QA
Review the applicable pharmacopoeia and guidelines and make appropriate updates
Review instrument calibration data w.r.t operating documents

Key Accountabilities (2/6)

Review the latest pharmacopeial updates, supplements and amendments by evaluating the updates required in the available document to ensure the compliance with the current pharmacopoeia through consent with regulatory body

Review the recent/revised monograph as per current pharmacopoeia




Review the latest pharmacopeial updates and monitor its timely implementation to avoid any non-conformances
Intimate the concerned stakeholders to initiate and complete activities before effective date of pharmacopoeia
Escalate non-conformances timely to avoid any delays in operation

Key Accountabilities (3/6)

Review the assigned documents by referring the concern backup and pre-defined quality procedure to ensure its compliance against the quality requirements

Follow the approved procedures and current Cipla policies for review approach by referring valid backup documents, SOPs etc. so that every document is complying w.r.t. the quality aspect of the product
Identify and discuss queries / problems faced during the document review by taking initiatives so that further delay in document completion is avoided

Key Accountabilities (4/6)

Issue documents to applicable units, by maintaining the record of the same in the issuance

📌 Team Member (India)
🏢 Bioksha
📍 India