Team Member

**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 summary**
We are seeking a Validation to oversee the compliance of revalidation schedules across sterile injectables (Manufacturing, Quality Control, and Development). This pivotal role involves validating/revalidating facilities, utilities, equipment, and processes in strict accordance with applicable regulatory guidelines, ensuring adherence to regulatory requirements.

**Roles & Responsibilities**
- You will be responsible for ensuring compliance with the periodic revalidation schedule for facility, equipment, Media fill in Production, QC (Quality Control), and development areas. Your role includes adhering to the VMP (Validation Master Plan), resource planning, and overseeing the execution of revalidation processes.
- You will be responsible for development and review of Validation master documents such as VMP, validation plan, Standard Operating Procedures, Process validation and Cleaning validation protocols and reports in accordance with current GMP (Good Manufacturing Practices), company standards, policies and other regulatory requirements.
- You will be responsible for timely implementation of new systems and improvements with respect to validation in accordance to applicable regulatory guidelines, and closure of change controls.
- You will involve in validation activities as part of the facility design, equipment and utilities by developing and reviewing URS DQ (User Requirement Specification Design Qualification), FAT (Factory Acceptance Test), SAT (Site Acceptance Test), MC (Master Configuration), CTP (Commissioning Test Protocol), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) and VQ (Validation Qualification) in accordance with applicable regulatory guidelines.
- You will be responsible for maintaining a close liaison with engineers and vendors regarding facility and equipment items to ensure provision of accurate information, along with vendor package of qualification documentation.
- You will support FATs, SATs, IQ/OQ plant and equipment as required, advising team members to deliver best practice.
- You will be responsible for supporting internal and external audits, developing CAPA (Corrective and Preventive Actions) proposals, and ensuring QMS (Quality Management systems) compliance within the validation function.
- Additionally, your role involves goal setting, performance reviews, training, coaching, managing employee performance, and fostering a culture of recognition and appreciation to achieve individual, departmental, and business objectives.

**Qualifications**
**Educational qualification**:A Bachelor’s or Master’s in B.sc / M.sc or Bachelor’s or Master’s in Pharmacy

**Minimum work experience**:03 to 06 years of experience in Validation and Process engineering in Pharmaceutical or sterile injectables, with at least 2 to 4 years in leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing

**Skills & attributes**:
***
**Tech