Quality Control Associate Areas, Utilities & Monitoring

Job Summary 

We are seeking a Quality Assurance 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.

Qualifications :

Educational qualification: . in Microbiology or Biotechnology as major preferred

Minimum work experience: 2 years

Skills & attributes: 

• Strong Aseptic operation skills to ensure aseptic behavior in cleanroom.
• Knowledge on cleanroom operations environmental monitoring techniques.
• Knowledge on operation of Labware LIMS and trouble shooting in case of software failure.
• Knowledge on operation of various Microbiology Equipment instruments and handling of breakdowns/preventive maintenance of such equipment/instruments.

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