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 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 summary We are seeking an individual to verify compliance for activities in the respective counter function regularly This role involves reviewing real-time investigations ensuring smooth batch manufacturing and testing activities and evaluating practices against defined standards to ensure consistent product quality and operational compliance within the regulatory framework and global standards Roles Responsibilities You will be responsible for executing or assigning in-process activities during shifts conducting line clearances material verification overseeing start-up of machines and coordinating sampling activities to ensure product quality and compliance You will be responsible for executing or assigning the execution of batch records and log books filling in various applicable formats including line clearance and sampling formats along with batch records review sheets Your tasks also involve reviewing the records maintained by the Production team creating additional records as needed conducting all documentation with respect to Quality Assurance QA activities ensuring that documentation is happening online and follow the incident reporting system in the case of deviations You will be responsible for issuance availability and adherence of approved procedures to the manufacturing team You will be tasked with checking the adherence to the Quality Management System QMS elements such as change control incident management and CAPA Corrective and Preventive Actions management on the shop floor Your responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice GMP requirements at all times including facility upkeep environmental conditions segregation of materials and status labeling In case of deviations you will follow the incident management process You will provide essential support to the supervisor in conducting investigations related to complaints batch failures Out-of-Specification Out-of-Trend OOS OOT results incidents etc by collating data and conducting interviews You will coordinate with cross-functional teams to facilitate and drive the investigation process conduct a thorough root cause analysis document CAPA verify implementation within the agreed timeline and monitor its effectiveness over time You will be responsible for supporting or assigning personnel to assist in internal and external audit activities following the instructions of superiors providing necessary information documents and clarifications to supervisors during actual audits and maintaining appropriate records You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed QualificationsEducational qualification A B Pharm or Post-Graduation Life Sciences Minimum work experience 4 years of industrial experience with specific operational experience in Manufacturing Quality Control Quality Assurance or Engineering DevelopmentSkills attributes Technical Skills A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization In-depth knowledge and comprehension of the Bio Pharma and Pharma markets including product knowledge market trends competitors and customer needs Understanding and familiarity with global cGMP Current GMP regulatory requirements including those set by FDA U S Food and Drug Administration EU European Union and Indian regulatory authorities Awareness of broader market dynamics industry trends and factors influencing the pharmaceutical market Comprehensive knowledge of the specific products associated with the pharmaceutical organization including their characteristics manufacturing processes and quality requirements Ability to understand and implement organizational policies and ensuring compliance Behavioural skills Demonstrates a commitment to continuous learning Strong communicating and influencing skills Displays analytical and logical thinking abilities Is self-motivated and takes initiative Adaptability to the work environment along with being a team player Ability to go beyond boundaries showcasing a proactive and innovative approach Additional InformationAbout 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