eCompliance Specialist at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

28 May, 26

Salary

0.0

Posted On

27 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Csv Principles, Risk-Based Validation Strategies, Testing Protocols, Documentation Requirements, 21 CFR Part 11, Annex 11, GAMP Guidelines, Validation Lifecycle Management Systems, Electronic Document Management Systems, It Change Management, Quality Management Systems, Quality Assurance, Compliance Frameworks, Risk Management, Change Management, Manufacturing Automation

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 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 1. CSV Lead for assigned projects; responsibilities include but not limited to vendor evaluation, creation of System Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems. 2. Perform system risk assessments and review action plans to ensure compliance during and after the system validation. 3. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and version release protocols. 4. Develop and review computer system validation deliverables for accuracy, consistency, clarity, and completeness. 5. Reviewing, approving Test script/ Qualification - Perform assigned activities, deliverables, CFT meeting co-ordination 6. Help, guide and direct the project manager during the system implementation and validation process, ensure compliance with Dr. Reddy’s policies and procedures. 7. Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel. 8. Ensure the compliance of computerized systems to regulatory requirements, including but not limited to 21 CFR Part 11 and other applicable regulations. 9. Review of change controls with respect to business process, any changes in IT system. Review of validation deliverables for IT Change Requests; Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects. 10. Facing regulatory, customer, IT Quality System related inspections for all computerized systems across the company. 11. Review of computerized systems post go-live to ensure compliance with the applicable procedures. 12. Undertake knowledge management initiatives (GxP awareness, Compliance sustenance) like Trainer-Training related to CSV/quality /compliance to cross functional teams. Qualifications Educational qualification: A Bachelor’s or Master’s in Computer Science, Information Technology, or related field Minimum work experience: 7 to 11 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, Annex 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. • Good time management and organizational skills. • Team player with good communication and interpersonal skills. • Attention to detail and commitment to quality of work. 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: 6 - 12 Business unit: GMO

Responsibilities

The specialist will act as the CSV Lead for assigned projects, managing vendor evaluation, creating System Validation Plans based on system criticality, and performing system risk assessments. They will also define risk-based validation strategies, develop and review validation deliverables, and ensure compliance with regulatory requirements like 21 CFR Part 11.