Lead eCompliance Specialist at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

03 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CSV Leadership, Regulatory Inspection Handling, Audit Defense, Risk-Based Validation, Problem Solving, Vendor Management, Stakeholder Management, Strong Communication, Decision-Making

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 We are looking for a Lead eCompliance Specialist to execute strategic plans and roadmaps for CSV activities, ensuring adherence to timelines, budgets, and quality standards. Your role will involve collaborating with vendors, performing risk assessments, and defining risk-based validation strategies. By overseeing CSV deliverables, conducting qualification activities, and ensuring compliance with regulatory requirements, you will play a crucial role in maintaining the integrity and reliability of our computerized systems. You will also drive process improvement initiatives and foster a culture of continuous learning. Roles & Responsibilities Role Overview We are seeking a Lead eCompliance Specialist – Computer System Validation (CSV) to lead our enterprise CSV practice and ensure the validated state and compliance of GxP computerized systems, IT applications, and automation platforms across sites. This role requires strong people leadership, vendor management, and hands‑on regulatory inspection experience, with accountability for CSV governance, delivery, and continuous compliance improvement. Key Responsibilities Lead and manage a team of CSV specialists across sites and projects; drive capability building and performance. Own and maintain the validated state of GxP computerized systems throughout their lifecycle. Lead CSV activities for system implementations, upgrades, and enhancements using a risk‑based validation approach. Evaluate IT/automation solutions and vendors for GxP, data‑integrity, and regulatory compliance. Manage and govern the validation software platform(s) used for CSV execution (e.g., validation lifecycle tools, e‑validation systems) Review and approve CSV deliverables including validation plans, test scripts, qualification protocols, and FAT/SAT documentation. Ensure compliance with GDP, GMP, and SDLC requirements. Act as the CSV subject‑matter expert during regulatory inspections and audits; lead inspection readiness, responses, CAPAs, and remediation activities. Establish and sustain CSV governance, KPIs, and continuous improvement initiatives. Collaborate closely with QA, IT, Engineering, Manufacturing, and external partners. Establish and maintain CSV governance, KPIs, and reporting mechanisms. Drive standardization and continuous improvement based on: Audit and inspection outcomes Regulatory updates. Lessons learned and stakeholder feedback Lead CSV‑focused training and awareness programs across functions. Partner and vendor management, including: End‑to‑end ownership of commercials, contracts, renewals, and cost optimization. Evaluation of vendor proposals and business cases. Monitoring partner performance against contractual and compliance commitments Qualifications Qualifications & Experience Bachelor’s or Master’s degree in Engineering, Pharmacy, Computer Science, Life Sciences, or related discipline. 13–15 years of experience in CSV / IT Compliance / Digital Quality, with: Proven people‑management experience Multi‑site or enterprise‑level CSV exposure Hands‑on experience supporting regulatory inspections Strong working knowledge of: 21 CFR Part 11 EU Annex 11 GAMP 5 Data Integrity principles Key Skills CSV leadership and governance Regulatory inspection handling and audit defense Risk‑based validation and problem solving Vendor and stakeholder management Strong communication and decision‑making skills Additional Information About the Department Digital Process and Excellence (DPEx) Our digital transformation journey is led by the DPEx team and is structured along the lines of Digitalize the Core and Transform with Digital. With a mandate to ensure continuous process improvement and drive patient centric innovation, it spans all functions and operations. In other words, you could be working on projects to expedite research outcomes one day, designing customer engagement platforms the next and simplifying warehouse processes the third. Some its priorities are: • Reimagine Dr. Reddy’s as a ‘platform-based’ organization. • Create Data as an asset that brings competitive advantage and business impact. • Create Digital solutions that make the lives of our patients and customers easier and better. 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: Digital Product and Technology Sub Job Family: Manufacturing Execution Systems/ Computer System Validation Preferred type of working: On-Premise Years of Experience: 12-Jun Business unit: GMO

Responsibilities

The Lead eCompliance Specialist will lead the enterprise Computer System Validation (CSV) practice, ensuring compliance and the validated state of GxP computerized systems. This includes managing a team, overseeing CSV deliverables, and driving continuous improvement initiatives.