Quality Control Associate - Compliance at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

13 Aug, 26

Salary

0.0

Posted On

15 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Change Control Management, SOP Revision, CAPA Oversight, QMS Tracking, Audit Support, Gemba Inspections, GMP, ISO Standards, LIMS, SAP, Root Cause Analysis, Document Control, Quality Control, Compliance Management, Regulatory Affairs, Impact Assessment

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 The QC Compliance Specialist ensures that all quality control operations comply with internal procedures and external regulatory standards. This role is pivotal in managing documentation, driving continuous improvement, and maintaining audit readiness. Key Responsibilities · Change Control Management: o Initiate, evaluate, and track change controls related to QC processes, instrumentation, and documentation. o Ensure proper impact assessments and timely implementation of approved changes. · STP and SOP Revisions: o Review, revise, and maintain Standard Test Procedures (STPs) and Standard Operating Procedures (SOPs) to reflect current practices and regulatory updates. o Collaborate with QC analysts and QA to ensure clarity, accuracy, and compliance in documentation. · CAPA Oversight: o Support investigation and closure of Corrective and Preventive Actions (CAPAs). o Ensure root cause analysis and effectiveness checks are properly documented. · QMS Tracking and Documentation: o Maintain Quality Management System (QMS) records including deviations, investigations, and audit findings. o Monitor and report status of quality events to ensure timely resolution and compliance. · Timeline Adherence: o Track due dates for all quality system activities and ensure no overdue items. o Escalate delays and coordinate with stakeholders to meet regulatory and internal deadlines. · Audit and Inspection Support: o Prepare documentation and participate in internal and external audits. o Ensure readiness and compliance with applicable standards. · Gemba Inspections: o Conduct routine GEMBA walks to observe QC operations directly at the source. o Identify gaps in compliance, documentation, and execution through real-time observation. o Document findings and follow up on corrective actions to ensure closure and effectiveness. " Qualifications Qualifications · Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or related field. · 4–7 years of experience in a regulated QC or QA environment. · Familiarity with GMP, ISO standards, and regulatory expectations (e.g., FDA, EMA). · Hands-on experience with Quality Management Systems (QMS) for tracking CAPAs, change controls, deviations, and document revisions. · Proficiency in QMS platforms (e.g., LIMS, DocHub, Qualex, SAP. Fyori....) and document control systems. · Strong attention to detail, organizational skills, and ability to manage timelines effectively.. Behavioural Skills Self-starter. Team player. Excellent oral and written communication skills. " Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible, and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions for patients globally. We have end-to-end capabilities in: API (Active Pharmaceutical Ingredients) Formulations Clinical Intellectual Property Regulatory Affairs We are serving 55+ markets, including USA, Canada, Europe, China, LATAM, ASEAN, and all Emerging Markets with innovative and generic products ranging from: Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables, Ophthalmics) Other dosages Our product development efforts drive a portfolio of more than 1,000 products. Enabled by our robust R&D team consisting of over 200 scientists and functional experts, including more than 150 doctorates, we have filed 1,071 patents and published over 1,000 papers for peer review over the years. " 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: 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 also 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. 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 Control Preferred type of working: On-Premise Business unit: Biologics

Responsibilities

The QC Compliance Specialist ensures all quality control operations adhere to internal procedures and external regulatory standards. Key duties include managing change controls, revising SOPs, overseeing CAPAs, and conducting Gemba inspections to maintain audit readiness.