Cipla Ltd Hiring freshers & Experience Bsc,Msc,Bpharm,Mpharm for Junior Team Member – QA/QC/Junior Officer – Packing/ADL Analyst

Job Purpose

Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines

Key Accountabilities (1/6)

Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner

Collect data from all SPOCs with respect to received work plan for review

Escalate any delays in receiving response from unit with respect to work plan

Review of collected data for work plan fulfilment

Send data to HO for compilation of deficiency response

Take follow up with HO to receive updated dossier for product updates

Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies

Job Purpose

Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements                                                

Key Accountabilities (1/6)

Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission

Conduct extensive literature search

Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTI’s on different analytical instruments under GLP environment

Conduct Fate and Purge studies/carryover studies

Perform method validation

Prepare specification based on carryover studies

Perform method transfer to manufacturing units for routine QC analysis