eCompliance Specialist

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 Summary
We are looking for a eCompliance Specialist to execute strategic plans and roadmaps for CSV activities, ensuring adherence to timelines, budgets, and quality standards. Your role involves collaborating with vendors, performing risk assessments, defining validation strategies, and overseeing the development of CSV deliverables. Additionally, you will develop subject matter expertise, guide project managers during system implementation, ensure regulatory compliance, and contribute to team’s success.

Roles & Responsibilities
• You will be responsible for execution of strategic plans and roadmaps for Computer Systems Validation (CSV) activities for assigned projects, ensuring implementation within timelines, budget and quality standards.
• You will be responsible for vendor evaluation and vendor collaboration for CSV activities
• You will perform risk assessments and review action plans to ensure end-to-end compliance.
• You will be responsible for defining risk-based strategies for system validation, including validation methodologies, testing activities, documentation, and version release protocols.
• You will develop and review CSV deliverables for accuracy, consistency, clarity, and completeness. You will also review and approve test scripts.
• For qualification activities, you will perform assigned tasks, create deliverables and coordinate cross-functional team meetings.
• You will be responsible for helping and guiding the project manager during system implementation and validation process, ensuring compliance with policies and procedures.
• You will train users and appropriate personnel on CSV, quality and compliance.
• You will ensure compliance to all applicable regulatory requirements (e.g. 21 CFR Part 11).
• You will be responsible for reviewing change controls related to business processes and any IT system changes. You will also review validation deliverables for IT Change Requests. 
• Your role involves establishing and implementing corrective and preventive actions, as well as leading process improvement initiatives for CSV projects.
• Your role also involves facing regulatory, customer and IT Quality System related inspections for all computerized systems across the organization.
• You will be responsible for periodic review of computerized systems post go-live, ensuring compliance with the applicable procedures.
• You will undertake knowledge management initiatives such as GxP (Best Practices) awareness, compliance sustenance, Trainer-Training sessions related to CSV, quality, and compliance for cross functional teams.
• You will develop and modify procedures for CSV activities and related system specific qualification activities.
• You will be responsible for improving your productivity and performance, developing subject matter expertise, and contributing to the success of the team.

Educational qualification: A Bachelor’s or Master’s in Computer Science, Information Technology, or related field

Minimum work experience: 8 to 15 years of experience

Skills & attributes:
Technical Skills
• In-depth knowledge of CSV principles and methodologies, including risk-based validation strategies, testing protocols, and documentation requirements.
• Proficiency in regulatory requirements related to CSV, such as 21 CFR Part 11, Annexure 11, and GAMP guidelines.
• Experience with validation tools and software, including validation lifecycle management systems (VLMS) and electronic document management systems (EDMS).
• Familiarity with IT Change Management processes and change control procedures in regulated environments.
• Strong understanding of quality management systems (QMS), quality assurance (QA), and compliance frameworks.
• Ability to perform comprehensive risk and change management for computerized systems.
• Foundational knowledge on manufacturing and automation in the context of computerized systems validation.

Behavioural skills
• Ability to perform tasks independently with minimal supervision, showcasing self-reliance and autonomy.
• Teamwork and collaboration skills to work effectively in a multidisciplinary environment
   and Ability to monitor and manage small team of consultants
• Good time management and organizational skills.
• Team player with good communication and interpersonal skills.
• Attention to detail and commitment to quality of work.

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/#!/