Team Member - Qualification

Dr. Reddy’s Laboratories Ltd; Visakhapatnam; On-site; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Relocation support

Medical coverage

Maternity & Paternity benefits

Learning & development opportunities

Life coverage

Job summary

Dr. Reddy’s Laboratories Ltd in Visakhapatnam seeks an experienced Qualification professional to manage documentation and execution of qualification activities across URS, DQ, FDS, IQ, OQ, PQ and related GMP processes.

You will review risk assessments, prepare validation master plans, CAPA actions, and support regulatory inspections, training staff and vendors, ensuring compliance and timely closures.

Qualifications

• Degree in pharmacy or engineering is required.
• Experience in qualification activities and GMP/compliance is essential.
• Strong documentation and data review skills are expected.

Responsibilities

• Documentation and execution of URS, DQ, FDS, IQ, OQ, PQ, and RQ documents.
• Review risk assessments for equipment and systems.
• Manage FAT/SAT activities and compile raw data and supporting certificates.
• Prepare and review validation protocols and final reports.
• Lead CAPA projects and support regulatory inspections.
• Prepare VMP and assist with training of staff and vendors.
• Coordinate qualification schedules and support transfer of equipment.

Skills

URS

DQ

FDS

IQ

OQ

PQ

RQ

Validation

Education

B.Pharm

M.Pharm

B.Tech

M.Tech

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.

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

Minimum Work Experience

8 to 12 years overall experience

Additional Information

Benefits Offered

At Dr. Reddy’s we actively help to catalise 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/#!/