Team Member_QC

ob 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

Accountabilities

I. 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

II. 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 new/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 activitiarmacopoeia
�� Escalate non-conformances timely to avoid any delays in operation

III. 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

IV. Issue documents to applicable units, by maintaining the record of the same in the issuance record (bound book) so the current version of the common document is available at the unit

��� Issue applicable bound books to units by maintaining the log of the same so the current format is available to record the relevaýýý Maintain correct and updated record of all the issuance of documents and bound books

V. Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed
ýýý Evaluate and prepare documents for standardization across all units at a site
ýýý Coordinate with CFTs and check requirements as per existing procedures to simplify the process
ýýý Provide suggestions and ideas by exploring new possibilities to achieve work simplification.