Team Member - Qualification

Dr Reddy's Laboratories Limited; Visakhapatnam; On-site; INR 1,400,000 - 2,200,000; Full time

Benefits offered by this job

Joining & relocation support

Medical coverage for you and family

Life coverage for yourself

Learning and development opportunities

Job summary

Dr. Reddy’s Laboratories Limited in Visakhapatnam is seeking a seasoned Qualification Specialist to manage the documentation and execution of qualification activities, ensuring adherence to validation master plans and SOPs.

The role includes reviewing data, supporting CAPA, and assisting during regulatory inspections. The ideal candidate holds a B.Pharm/M.Pharm or B.Tech/M.Tech with 8–12 years of relevant experience in qualification activities and regulatory compliance, and will train staff and

Qualifications

• Bachelor or Master’s degree in pharmacy or engineering as listed.
• 8–12 years of overall experience in qualification activities.
• Experience in QA/validation documentation and regulatory support.

Responsibilities

• Manage documentation and execution of qualification activities, including URS, DQ, FDS, UTM, IQ/OQ/PQ/RQ.
• Review risk assessments for equipment and systems.
• Oversee FAT and SAT for new projects.
• Prepare and review protocols and reports for media fill and cleaning validation.
• Initiate CRNs and manage CAPA implementation.
• Support regulatory, internal and external inspections.

Skills

Documentation

Validation

CAPA handling

Regulatory inspections

Education

B.Pharm

M.Pharm

B.Tech

M.Tech

Tools

MS Office

Job 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

We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities, including the preparation, review, and execution of various qualification documents. The ideal candidate will oversee new project-related tests, review and compile raw data, and ensure compliance with validation master plans and SOPs. Additionally, responsibilities include implementing corrective and preventive actions, conducting incident investigations, and providing support during regulatory inspections.

Roles & Responsibilities

• You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents.
• Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems.
• You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).
• You will review and compile raw data, relevant certificates, analysis test reports and preparation and review of final summary report.
• You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation.
• Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.
• You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification.
• As part of your role, you will prepare and review VMP (Validation Master Plan).
• You will conduct training for employees and external vendors as a qualified trainer.
• Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label.
• You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment.
• You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Qualifications

Educational Qualification

B. Pharm, M.Pharm, B.Tech, M.Tech

8 to 12 years overall experience

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.

• 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.