Urgent: Quality Assurance 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 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 currently seeking a highly motivated collaborative and experienced Quality Assurance QA personnel who can assist in establishing our CAR-T manufacturing GMP facility in Bangalore India The ideal candidate should have prior experience in field of biologics and cell therapy This is a multi-disciplinary role and candidate will interface across multiple parts of the company Responsibilities To assist in ensuring the quality management system and all aspects of cGMP are effectively established implemented and maintained in accordance with the regulatory and company standards Provide QA oversight for all cGMP related activities operations and QC Review of quality system records such as change controls deviations complaints investigations and customer complaints Partners with other functions in for ensuring QMS elements are complying to regulatory and company standards Works closely with other functions in a cooperative fashion and ensure project progression To provide QA oversight to the commissioning and qualification activities on site Develop author review and or approve standard operating procedures specifications regulatory filing information and other controlled documents as required May participate in internal external audits and regulatory inspections Perform or support any other tasks necessary to maintain the product quality and cGMP compliance Behavioral skills Communication Clearly communicate with team members other departments and management to ensure efficient workflow and collaboration Critical Thinking Evaluate data and information critically to make informed decisions and optimize quality operations processes Problem-Solving Ability to analyze complex issues and develop effective solutions to ensure compliance with regulations Teamwork Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes Time Management Prioritize tasks meet deadlines and ensure timely completion of projects while maintaining quality standards Qualifications Bachelor s degree or higher in Pharmacy or related life sciences field 2 - 6 years of relevant experience in the biopharmaceutical or cell therapy industry Experience with Cell and Gene therapy products preferred Good knowledge of Good Manufacturing Practices Familiarity and understanding of FDA EU and local industrial requirements