Sr eCompliance Associate

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.

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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/Annexure 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.

Educational qualification

Engineering /IT/Science graduate with Pharma industry experience

Minimum work experience

4 to 10 years of experience

Mandatory skills

• CSV , Software Testing, Manufacturing, Quality ,Automation, Risk/ Change Management ,GAMP5, 21CFR part11, EU Annexure 11

About the Department - Global Manufacturing Organisation (GMO)

At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.

We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.

Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.

For more details, please visit our career website at https://careers.drreddys.com/#!/