Sr Ecompliance Associate

Company DescriptionDr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparencyDr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization Roles Responsibilities 1 CSV Lead for assigned projects responsibilities include but not limited to vendor evaluation creation of System Validation Plan based on the criticality of the proposed system in consensus with the vendor based on their Quality Systems 2 Perform system risk assessments and review action plans to ensure compliance during and after the system validation 3 Define risk-based strategies for the validation of the systems which includes but not limited to validation methodologies testing activities documentation and version release protocols 4 Develop and review computer system validation deliverables for accuracy consistency clarity and completeness 5 Reviewing approving Test script Qualification - Perform assigned activities deliverables CFT meeting co-ordination6 Help guide and direct the project manager during the system implementation and validation process ensure compliance with Dr Reddy s policies and procedures 7 Provide training related to computerized systems validation quality and compliance to users and appropriate personnel 8 Ensure the compliance of computerized systems to regulatory requirements including but not limited to 21 CFR Part 11 Annexure 11 and other applicable regulations 9 Review of change controls with respect to business process any changes in IT system Review of validation deliverables for IT Change Requests Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects 10 Facing regulatory customer IT Quality System related inspections for all computerized systems across the company 11 Review of computerized systems post go-live to ensure compliance with the applicable procedures 12 Undertake knowledge management initiatives GxP awareness Compliance sustenance like Trainer-Training related to CSV quality compliance to cross functional teams QualificationsEducational qualificationEngineering IT Science graduate with Pharma industry experienceMinimum work experience4 to 10 years of experienceMandatory skills CSV Software Testing Manufacturing Quality Automation Risk Change Management GAMP5 21CFR part11 EU Annexure 11 Additional InformationAbout the Department - Global Manufacturing Organisation GMO At Dr Reddy s Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation With a legacy of excellence we are a leading force in the pharmaceutical industry We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries We manufacture a portfolio of complex APIs and 1 150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes The World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network We aspire to be the most efficient pharma operations in the world Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals Building such factories of the future is integral to innovation and to build healthcare of the future For more details please visit our career website at