Msat Specialist

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 Job SummaryWe are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes including authoring validation protocols and reports conducting risk assessments and utilizing advanced tools for process monitoring and analysis Your role will involve active participation in technology transfers continuous improvement initiatives and ensuring compliance across manufacturing operations Roles Responsibilities Responsible for Validation which shall include Preparation Review Approve of MPR Preparation Review Approve of process validation protocols Preparation Review Approve compilation of validation report Responsible for Tech transfer which shall include Coordination with Vendor cross functional teams for Tech transfer activities Execution of Tech transfer products at Receiving Units Responsible for QIP which shall include Identifying root cause for QIP Execution of QIP Conclusion Recommendation of QIP Responsible for OOS OOT investigation which shall include Identifying probable and most probable root cause for OOS OOT Ensure that validations is carried out as per the protocol qualification protocols meets the cGMP regulatory requirements Follow up coordinate with cross functional team for execution of validation Give the input for the monthly reporting system participate in the internal external audits present the documents to auditor s inspection team QualificationsEducational qualification Masters Bachelors Ph D in pharmaMinimum work experience 6-8 years of experience in Process development MSAT Tech transferSkills attributes Technical Skills Experience in the scale up technology transfer of products in relevant dosage forms or technologies OSD Experience in process Engineering Quality by Design QbD principles and risk assessment approaches Knowledge of International Council for Harmonization ICH guidelines related to Product development or Process Development Additional InformationAbout the DepartmentIntegrated Product Development OrganisationWe integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients API Oral formulations Parenteral Injectables Opthalmics Other dosages Our product development efforts drive a portfolio of more than 1 000 products Enabled by our robust R D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1 071 patents and also published over 1 000 papers for peer review over the years