Team Member Qualifications

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.

Additional Information :

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time