Quality Control Associate - Microbiology

Company Description

Job Description

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.

Qualifications

Qualifications

Experience - 2 to 6years
Should be qualified as M.Sc Microbiology

Additional Information

Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

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.

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/#!/