Qualification and Validation Specialist

Dr Reddys Laboratories; Visakhapatnam District; On-site; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Joining & relocation support

Family support (Maternity & Paternity)

Learning and development opportunities

Medical coverage for yourself and your

Life coverage

Job summary

Dr. Reddy's Laboratories Ltd. is seeking a Qualification & Validation Specialist to execute IQ/OQ/PQ protocols, coordinate with vendors, and ensure cGMP compliance.

The role involves preparing risk assessments, SOPs, validation programs, and master plans, while supporting audit responses and QA CAPA processes. The candidate will contribute to safety risk assessments, digital system implementations (eVal), and audits with cross-functional teams, driving continuous improvement in qualification

Qualifications

• Educational qualification: Graduation in Pharmacy, Science, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electrical Engineering, Biotechnology or related field is mandatory.
• Minimum work experience: 8 to 10 years of experience.

Responsibilities

• Execute qualification protocols (IQ, OQ, PQ) and coordinate with vendors and cross-functional teams.
• Compile qualification documents and prepare risk assessments, SOPs, validation programs, and master plans.
• Execute equipment requalification as per schedule and update qualification schedules.
• Assist in audit responses, coordinating with QA for CAPA, incidents, deviations, and audit reports.
• Prepare master documents (SOPs, operating instructions, VMPs) and coordinate risk assessments for equipment/systems.
• Assess safety risks, drive implementation of safe procedures, and create awareness among team members.
• Support digital system implementation (eVal) and coordinate URS, DQ, and quantitative risk assessments with production and engineering.
• Coordinate with QA and engineering for cGMP document approvals and vendor audits.

Skills

Calibration

Change Control

Incident Reporting

Pharmaceutical Manufacturing

Preventive Maintenance

Qualification Protocols (IQ/OQ/PQ)

Regulatory Compliance

Education

Graduation in Pharmacy, Science, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electrical Engineering, Biotechnology or related field

Job description

Team Member Qualifications

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

This role is for a Qualification & Validation Specialist responsible for executing equipment and system qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The position involves coordinating with vendors and cross-functional teams, preparing risk assessments, SOPs, validation programs, and master plans, and ensuring compliance with cGMP standards. You will contribute to regulatory readiness by compiling qualification documents, supporting audit responses, and coordinating CAPA, incidents, and deviations. The role emphasizes safety risk assessments, digital system implementation (eVal), and vendor audits. Additionally, you will assist in preparing corrective actions, drive safety awareness, and support continuous improvement in qualification and validation practices.

Roles & Responsibilities

• You will be responsible for executing qualification protocols (IQ, OQ, PQ), coordinating with vendors and cross-functional teams.
• You will be responsible for compiling qualification documents, preparing risk assessments, SOPs, validation programs, and master plans.
• You will be responsible for executing equipment requalification as per schedule and updating qualification schedules.
• You will be responsible for assisting in audit responses, coordinating with QA for CAPA, incidents, deviations, and audit reports.
• You will be responsible for preparing master documents (SOPs, operating instructions, VMPs) and coordinating risk assessments for equipment/systems.
• You will be responsible for assessing safety risks, driving implementation of safe procedures, and creating awareness among team members.
• You will be responsible for supporting digital system implementation (eVal) and coordinating URS, DQ, and quantitative risk assessments with production and engineering.
• You will be responsible for coordinating with QA and engineering for cGMP document approvals and vendor audits.

Qualifications

Educational qualification: Graduation in Pharmacy, Science, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electrical Engineering, Biotechnology or related field is mandatory.

Minimum work experience: 8 to 10 years of experience.

Skills & attributes &Critical exposures

Functional Skills

• Calibration
• Change Control
• Incident Reporting
• Pharmaceutical Manufacturing
• Preventive Maintenance
• Qualification Protocols (IQ/OQ/PQ)
• Regulatory Compliance

Resident Skills

• Current Good Manufacturing Practices (cGMPS)
• Quality Management Systems
• Data Analysis
• Good Documentation Practices
• Lean Methodologies

Behavioural Skills

• Detail-oriented with strong compliance and regulatory alignment mindset
• Collaborative across vendors, engineering, QA, and cross-functional teams
• Continuous improvement orientation with problem-solving and innovation

Critical exposures

• Experience in qualification of pharmaceutical equipment, clean utilities and process equipment with basic understanding of computer system validation is desired.
• Experience in risk assessments and ensuring traceability, documentation integrity, and validation process is desired.
• Exposure to greenfield and brownfield plant setup activities is preferred.
• Exposure to audit response and compliance reporting, ensuring timely closure of gaps is preferred.

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.

Experience Level

Senior Level