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

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

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

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

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

V. Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed

M.Sc. / B. Pharma

2 years of experience in QC department of a pharmaceutical organization