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)
Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic
Maintain system integrity by updating documentations and deviations on CipDox while performing operations
Maintain all the online documentation and timely entries and supporting documents
Prepare new documents and update existing documents as per GMP requirement
Key Accountabilities (4/6)
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 avai
📌 Junior Team Member (Rangpo)
🏢 Cipla
📍 Rangpo