Quality By Design
3 weeks ago
Company Description Dr 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 transparency Dr 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 We are seeking a detail-oriented and analytical Specialist Quality by Design QbD to join our team in Hyderabad India In this role you will be responsible for implementing and maintaining QbD principles throughout our pharmaceutical manufacturing processes ensuring high-quality products and regulatory compliance Develop and implement QbD strategies for new and existing products Conduct risk assessments and design of experiments DoE to optimize manufacturing processes Analyze and interpret complex data sets to identify critical quality attributes and process parameters Collaborate with cross-functional teams to integrate QbD principles into product development and manufacturing Develop and maintain documentation related to QbD initiatives including risk assessment reports and control strategies Provide technical expertise and training on QbD methodologies to team members Monitor and evaluate the effectiveness of QbD implementation recommending improvements as needed Ensure compliance with regulatory requirements and industry standards related to QbD Participate in regulatory inspections and audits providing QbD-related information as required Qualifications Bachelor s or Master s degree in Chemical Engineering Pharmaceutical Sciences or a related field 4-8 years of experience in QbD implementation within the pharmaceutical or biotechnology industry Strong understanding of Quality by Design QbD principles and methodologies Proficiency in statistical analysis data interpretation and risk assessment techniques Experience with process analytical technology PAT and design of experiments DoE In-depth knowledge of pharmaceutical manufacturing processes Understanding of regulatory requirements FDA EMA related to QbD implementation Excellent problem-solving skills and attention to detail Strong communication and collaboration abilities Experience in process development and optimization Proficiency in relevant software tools for data analysis and reporting Certifications in Six Sigma or Lean Manufacturing preferred Additional Information About the Department Integrated Product Development Organisation We 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 Benefits Offered At Dr Reddy s we actively help to catalyse your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddy s are on par with the best industry standards They include among other things and other essential equipment joining relocation support family support Maternity Paternity benefits learning and development opportunities medical coverage for yourself and your family life coverage for yourself Our Work Culture Ask any employee at Dr Reddy s why they come to work every day and they ll say because Good Health Can t Wait This is our credo as well as the guiding principle behind all our actions We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and we re always attuned to the new and the next to empower people to stay fit And to do this we foster a culture of empathy and dynamism People are at the core of our journey over the last few decades They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic For more details please visit our career website at https careers drreddys com
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