Team Member – QC | Cipla Ltd | Goa

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

Accountabilities

• 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 pharmacopeia and guidelines and make appropriate updates
  • Review instrument calibration data w.r.t  operating documents
• Review the latest pharmacopeial updates, supplements, and amendments by evaluating the updates required in the available documentation to ensure compliance with the current pharmacopeia through consent from the regulatory body
  • Review the new/revised monograph as per current pharmacopeia
  • Review the latest pharmacopeial updates and monitor their 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 the operation
• Review the assigned documents by referring to 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

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

Education Qualification

M.Sc. / B. Pharma

Relevant Work Experience

1-3 years of experience in QC department of a pharmaceutical organization