Team Member – Analytical Quality Assurance (AQA) at Dr Reddy's Laboratories Limited

, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

16 Aug, 26

Salary

0.0

Posted On

18 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Technical Documentation, Change Control, Risk Management, Chromatography, Product Quality, cGMP, GLP, QMS, Analytical Data Integrity, Investigation Management, HPLC, GC, FTIR, UV-Vis, LIMS

Industry

Pharmaceutical Manufacturing

Description

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. Job Description Job Summary This role is for a Quality Assurance Specialist – Analytical Compliance, responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations, with a focus on analytical data integrity, investigation management, and documentation oversight. Roles & Responsibilities • You will be responsible for participating in investigations of Quality Management System (QMS) documents such as OOS, OOT, and laboratory deviations, and ensuring timely closures as per SOP timelines. • You will be responsible for preparing trending reports for OOS, OOT, and laboratory incidents, using analytical insights to support CAPA identification and process improvements. • You will be responsible for evaluating Change Controls and CAPA action plans, verifying their effectiveness to ensure resolution of root causes and prevention of recurrence. • You will be responsible for reviewing all analytical data generated in the Quality Control laboratory—including electronic and raw data—ensuring accuracy and compliance with relevant SOPs. • You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence. • You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures. • You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy. • Management of QMS notifications through DCMS. • Monitor and ensure cGLP (current Good Laboratory Practices) in Quality control and Micro Lab, and implementation of standard operating procedures. • Verification of audit trails for all the GxP computer systems at Quality Control Laboratory. • Preparation, Review, and approval of stability study protocols on LIMS. • You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms. Qualifications Educational qualification: Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry, or Pharmacy is preferred Minimum work experience: 5-8 years of experience Skills & attributes &Critical exposures Functional Skills • Regulatory Compliance • Regulatory Filings • Technical Documentation • Change Control • Laboratory Information • Risk Management • Chromatography Resident Skills • Product Quality (QA/QC) • Current Good Manufacturing Practices (cGMPS) • Good Laboratory Practice (GLP) • Quality Management Systems (QMS) Behavioural Skills • Accuracy & Discipline – Upholds rigorous documentation and testing standards to ensure error-free, compliant results. • Ownership – Proactively identifies risks, supports investigations, and maintains equipment readiness with accountability. • Continuous Learning – Shares knowledge with new joiners, troubleshoots effectively, and contributes to laboratory excellence. Critical exposures • Experience in ensuring compliance with GMP, GLP, and global regulatory standards is desired. • Exposure to executing analytical tests using techniques like HPLC, GC, FTIR, and UV-Vis, ensuring adherence to SOPs and regulatory requirements, is preferred. • Experience in maintaining accurate documentation and ensuring compliance with data integrity principles, such as 21 CFR Part 11 and Annex 11, is desired. • Experience in troubleshooting, like Out-of-Specification (OOS) results and non-conformances, applying analytical methodologies to resolve deviations, is desired. • For SME – Advanced Instrumentation: Experience in operating and maintaining advanced analytical instruments such as LC-MS, ICP-MS, and NMR, ensuring method development and validation, is desired. Additional Information 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/#!/ Job Family: Quality Sub Job Family: Quality Assurance Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: GMO

Responsibilities

Responsible for ensuring regulatory compliance and data integrity within Quality Control laboratory operations. This includes managing QMS investigations, reviewing analytical data, and overseeing stability study protocols.