Team Member

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 Rsponsible for managing the initial and periodic validation and qualification activities for various areas and facilities This includes drug substance and drug product manufacturing equipment cold storage equipment utilities media fill of aseptic areas and smoke studies The role requires a seasoned professional with experience in validation and qualification processes within the pharmaceutical or biotechnology industry specifically on injectables Key Responsibilities Validation and Qualification Management Manage the validation and qualification activities for manufacturing equipment such as Autoclaves Tunnels Lyophilizers Bioreactors and Dry-heat Sterilizers Handle the validation and qualification of cold storage equipment including Cold Rooms Deep Freezers Refrigerators Incubators Blast Freezers Freeze-Thaw units and Warehouse storage areas Ensure the validation and qualification of utilities such as Water systems Compressed air Nitrogen Oxygen and Carbon Dioxide systems Aseptic Area Management Manage media fill activities to ensure aseptic conditions are maintained Conduct and oversee smoke studies to validate airflow and contamination control in aseptic areas Documentation and Compliance Develop and maintain comprehensive validation and qualification protocols and reports Ensure all activities comply with regulatory requirements and internal SOPs Maintain accurate and detailed records of all validation and qualification activities Team Leadership Lead a team of validation and qualification specialists providing guidance training and performance management Foster a culture of continuous improvement and ensure the team stays updated with the latest industry standards and practices Project Management Plan coordinate and execute validation and qualification projects within defined timelines and budgets Collaborate with cross-functional teams including Quality Assurance Manufacturing and Engineering Risk Management Identify potential risks in validation and qualification processes and develop mitigation strategies Conduct risk assessments and ensure corrective and preventive actions are implemented effectively Continuous Improvement Drive continuous improvement initiatives to enhance validation and qualification processes Stay abreast of industry trends regulatory changes and technological advancements Qualifications Education Bachelor s degree in Engineering MSc or MPharm Life Sciences or a related field Experience 10-15 years of experience in validation and qualification within the pharmaceutical or biotechnology industry Skills Strong knowledge of validation and qualification principles and practices Excellent leadership and team management skills Proficiency in regulatory requirements and industry standards e g FDA EMA GMP Strong project management and organizational skills Excellent communication and interpersonal skills Ability to analyze complex data and make informed decisions Additional Requirements Ability to work in a fast-paced dynamic environment Strong problem-solving skills and attention to detail Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon With a robust portfolio of biosimilar products across key therapeutic areas covering US 80 Bn in innovator sales - future business pipeline covers a variety of product classes and therapy areas and new modalities Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products With a Product Development engine that has end-to-end capabilities - in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900 000 patients having benefited from our products till date 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