Quality Control Associate - Microbiology

Dr. Reddy's Laboratories; Hyderabad; On-site; INR 450,000 - 650,000; Full time

Job summary

Dr. Reddy’s Laboratories in India seeks a Quality Control Associate for Microbiology to manage daily Environmental Monitoring operations in the Manufacturing facility and microbiology lab, ensuring cleanrooms meet microbial and particulate standards through EM program design, execution, and oversight.

The role supports cGMP compliance by providing data on environmental conditions and proactively identifying contamination risks, with responsibilities spanning data management, trend analysis, EM

Responsibilities

• Routine Monitoring Activities
• Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs
• Environmental Monitoring through LIMS software
• Monitor cleanroom areas including ISO5/Grade A, Grade B, C and D
• Utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and non-viable particulate load
• Personnel monitoring and gowning qualification of personnel for cleanrooms
• Water sampling (Raw water, treated water, Purified water, WFI and Pure steam) and support cross-functional area qualification/requalification
• Maintain and calibrate EM equipment (e.g. particle counters, air samplers) and related accessories
• Train and qualify newly joined personnel in EM program and water sampling activity
• Data Management & Trending
• Record and review EM data accurately and timely
• Perform routine trend analysis of viable/non-viable data and report anomalies
• Participate in alert and action level excursions and support deviation management
• Prepare the Annual summary report for EM program with determination of Alert and Action levels
• Adhere to cGMP, GDP and internal SOP requirements
• Prepare and review EM protocols, SOPs and investigation/study reports
• Support in regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans

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.

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 seeking a Quality Control Associate for Microbiology for managing daily Environmental monitoring operations in the Manufacturing facility as well as in microbiology laboratory. The qualified individual shall ensure that cleanrooms and classified manufacturing environments meet microbial and particulate cleanliness standards through the design, execution, and oversight of the Environmental Monitoring (EM) Program. This role supports cGMP compliance by providing data on environmental conditions by proactively identifying the contamination risks.

Roles & Responsibilities

• Routine Monitoring Activities
• You will be responsible to perform Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs.
• You will be responsible to perform Environmental Monitoring through LIMS software.
• Monitor different cleanroom areas including ISO5/Grade A, Grade B, C and D.
• You will be responsible to perform utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and Non-viable particulate load.
• You will be responsible for personnel monitoring as well as gowning qualification of personnel who will be proposed to work in cleanrooms.
• You will be responsible to perform water sampling (Raw water, treated water, Purified water, WFI and Pure steam) and to support the cross-functional department in area qualification /requalification.
• You will be responsible to maintain and calibrate EM equipment (e.g. particle counters, air samplers) and related required accessories.
• You will be responsible to train and qualify newly joined personnel in EM program and water sampling activity.
• Data Management & Trending
• Record and Review EM data accurately and in a timely manner.
• Perform routine trend analysis of viable/non-viable data and report anomalies.
• Participate in alert and action level excursions and support deviation management.
• Prepare the Annual summary report for EM program along with determination of Alert and Action level based on the historical data.
• Compliance and Documentation:
• Adhere to cGMP, GDP and internal SOP requirements.
• Prepare and review EM protocols, SOPs and investigation/ study reports.
• Support in regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans.

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