Team Member Qualifications

Dr. Reddy's Laboratories; Simhachalam Hill; On-site; INR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Relocation support

Maternity benefits

Paternity benefits

Medical coverage

Life insurance

Learning & development

Job summary

Dr. Reddy’s Laboratories in India seeks a Qualification & Validation Specialist to execute IQ/OQ/PQ, coordinate with vendors, and prepare risk assessments, SOPs, validation programs, and master plans.

The role emphasizes safety risk assessments, digital system implementation (eVal), and regulatory readiness, with 8–10 years in pharmaceutical qualification and validation.

Qualifications

• Graduation in Pharmacy, Science, or engineering is mandatory.
• 8–10 years of experience in qualification and validation.
• Experience with IQ/OQ/PQ and regulatory compliance.
• Experience in risk assessments and document control.

Responsibilities

• Execute qualification protocols (IQ, OQ, PQ) and coordinate with vendors and cross-functional teams.
• Compile qualification documents, risk assessments, SOPs, validation programs, and master plans.
• Execute equipment requalification per schedule and update qualification calendars.
• Support audit responses and coordinate CAPA, incidents, deviations, and audit reports.
• Prepare master documents (SOPs, operating instructions, VMPs) and coordinate risk assessments.
• Drive safety risk assessments and promote safe procedures and awareness.
• Support digital systems implementation (eVal) and coordinate URS, DQ, risk assessments.
• 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

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.

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

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.

Additional Information

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/#!/