Quality Control Associate - LIMS

SmartRecruiters, Inc.; Medchal–Malkajgiri; On-site; INR 600,000 - 800,000; 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 for yourself

Job summary

Dr. Reddy’s Laboratories Ltd. is seeking a LIMS Master Data professional with 3+ years of hands-on experience in the Biologics/Biosimilar space. You will create, revise and verify LIMS master data, map processes, and ensure audit trails align with regulatory expectations.

The role requires knowledge of LIMS workflows, test methods, and collaboration with QA and end users to drive accurate data and compliant operations.

Qualifications

• Educational qualification: M.Sc. or B.Tech in Biotechnology, Microbiology, Biochemistry.
• Minimum work experience: 3+ years.
• Hands-on experience with LIMS master data creation and review.
• Ability to map processes and identify gaps in existing workflows.
• Effective communication with end users and QA teams.

Responsibilities

• Hands-on experience in LIMS master creation, revision, and review support.
• Knowledge of specifications, sample plans, test methods, calculations, inventory, schedules, reagent masters, and stability masters.
• Understanding of LIMS workflow configuration, approval workflows, and audit trail requirements.
• Experience in challenge testing and verification of configured masters against approved source documents.
• Understanding of QC analytical, microbiology, stability, raw material, packing material, and bioassay testing processes.
• Familiarity with specifications, STPs, methods, protocols, and laboratory workflows.
• Knowledge of analytical techniques such as HPLC, UPLC, TOC, BET, CE-SDS, HCD, HCP, particle count, and environmental monitoring
• Ability to interpret SOPs, Work Instructions, Specifications, Forms, Validation Reports, Qualification Protocols, and JOS documents.
• Understanding of change controls, deviations, CAPAs, OOT/OOS requirements, and audit trail review expectations.

Tools

LabWare LIMS

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.

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Job Description

• Hands-on experience in LIMS master creation, revision, and review support
• Knowledge of specifications, sample plans, test methods, calculations, inventory, schedules, reagent masters, and stability masters.
• Understanding of LIMS workflow configuration, approval workflows, and audit trail requirements.
• Experience in challenge testing and verification of configured masters against approved source documents
• Understanding of QC analytical, microbiology, stability, raw material, packing material, and bioassay testing processes.
• Familiarity with specifications, STPs, methods, protocols, and laboratory workflows.
• Knowledge of analytical techniques such as HPLC, UPLC, TOC, BET, CE-SDS, HCD, HCP, particle count, and environmental monitoring
• Ability to interpret SOPs, Work Instructions, Specifications, Forms, Validation Reports, Qualification Protocols, and JOS documents.
• Understanding of change controls, deviations, CAPAs, OOT/OOS requirements, and audit trail review expectations.

Qualifications

Educational qualification: An M.Sc., or B.Tech. in Biotechnology, Microbiology, Biochemistry,

Minimum work experience: 3+ years

Skills & attributes:

• Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends.
• Hands-on experience in LabWare LIMS master data creation
• Ability to do process mapping of a procedure.
• Ability to identify gaps in the existing process flows.
• Design, create master data and execute dry runs for verification.
• Effective communication with end users, CFT’s, line QA regarding the master data.
• Design logics and verification through dry runs.
• Execution of test scripts to enable qualification of instruments, new modules as per process flows.

Behavioural skills

• Prioritizes effective communication and demonstrates a performance-oriented mind-set.
• Effective verbal and written communication skills.
• Performance-oriented approach, consistently striving for high standards.
• Demonstrates flexibility in working shifts and a clear understanding of team dynamics.

Additional Information

Benefits Offered

• joining & relocation support
• family support (Maternity & Paternity benefits)
• learning and development opportunities
• medical coverage for yourself and your family
• life coverage for yourself

At Dr. Reddy’s we actively help to catalise your career growth and professional development through personalised learning programs.

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.