Responsible for overall site Quality operations

Data Integrity & Electronic data Management.CQA

Core Team leader for ensuring the Quality Operations across Dr.Reddys sites.Leading Analytical Assurance team and ensuring that my current Organization is free from Data Integrity issues.A well defined quality system keeps me to maintain a good state of quality culture across the Organization.I am proud to be a part of DrReddys...

To drive the quality functions across the site and to implement all the regulatory requirements

QMS team leaderAccounting all the QMS activities like Change controls, Deviations, OOS investigations, OOT investigations, Self-inspections, Market complaints & reviewing and authorizing all the Analytical documents.Also accountable for Qualification activities related to Equipment, Instrument,Facility & Utilities.Played key role on introduction of Software validations in the plant level after CQA initiation.

Leading QMS team.Handling of Market complaints, Documentation of QMS, Preparation of Audit compliance reports, Review of SOP's, Process validation & Cleaning validation documents, Preparation of Annual validation planners...etc

Giving Continuous training to operators and Executives on aseptic practices and cGMP.Achieved success on decreasing the documentation errors by giving the continuous training programme.Check list introduced for cleaning and decontamination on process equipments for routine operations.Leading team member in participating during regulatory audits like MHRA, ANVISA, TGA, EGUNDA (NDA) and USFDA & customer Audits.As a Sr.Executive in Quality Assurance I have a good knowledge on… Show more Giving Continuous training to operators and Executives on aseptic practices and cGMP.Achieved success on decreasing the documentation errors by giving the continuous training programme.Check list introduced for cleaning and decontamination on process equipments for routine operations.Leading team member in participating during regulatory audits like MHRA, ANVISA, TGA, EGUNDA (NDA) and USFDA & customer Audits.As a Sr.Executive in Quality Assurance I have a good knowledge on Handling of Market complaints, Documentation to Change controls and Deviations.Having experience in submissions to regulatory agencies like Europe & other Asia countries regarding the facility overview, product DMF submission.Having good Experience in APQR, OOS, CAPA and OOT investigation and document preparation and Non conformance investigations.Investigating the OOS in such a way not to reoccur the same again. Analyzing each individual equipment process, validation & capabilities, suggesting balance equipments to further increase production. Show less

Worked as a raw material analyst and having responsibility to prepare the volumetric solutions and its standadizationsJOB PROFILE: