Quality Control Associate - Bioassay ( Supervisor )

Job description

Job Summary We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines. " Roles & Responsibilities Your responsibilities encompass Bioassay testing for assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis. Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy. You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits. Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification. You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques. Educational Qualification An ., . or . in Microbiology, Biochemistry, or Biotechnology Minimum Work Experience 6 - 10 years Skills & Attributes Technical Skills: Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. Hands-on experience in cell based bioassays, SPR technique, FACS techniques. Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioassay (BA) Labs. Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics. Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP). Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques. Basic understanding about bioassay method validations. Behavioural Skills: Prioritizes effective communication and demonstrates a performance-oriented mind-set. Effective verbal and written communication skills. Performance-oriented approach, consistently striving for high standards. Demonstrates flexibility in working shifts and a clear understanding of team dynamics. 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... " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards... " 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... For more details, please visit our career website at 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. "