Executive/Sr. Executive - QA OSD (Documentation)

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com

1.To review and implement Quality Management System for cGMP compliance at site.
2.To review and approve of product design.
3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements.
4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR
5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site.
6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP.
7.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents.
8.Vendor Assessment.
9.Handling of OOS.
10Process validation and equipment cleaning validation.
11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized.
12.To export certification for batches intended for exports.
13.To release (approval or rejection) the batch manufactured at site.
14.To monitor qualification, validation and requalification activity at site.
15.To trend the data and analyses the trend.
16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable.
17. To investigate market compliant. Review response.
18.Handling of product recall.
19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority.
20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product.
21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.