Quality Assurance Associate - Microbiology Reviewer

Job Description

Role Summary:

Team Member QA˗ Microbiology ensuring overall compliance of Microbiology lab in terms of Environmental monitoring, Water testing, product testing, method validations, instrument and equipment calibrations/PM/RQ management, media and culture management and QMS elements.

Primary Responsibilities:

1. To Perform test‑level and sample‑level LIMS analytical data review and approval for:

• Bioburden/In‑process: Perform the verification of Bioburden/In-process, contamination check plates and review the relevant test data.
• MLT (Microbial Limits Testing): Perform verification of TAMC/TYMC, test for specified organisms’ plates/tubes, etc. and review the MLT data.
• Utilities (Water & Process Gases): Perform verification of test samples or plates PW/WFI/Clean Steam/Compressed Air/ Nitrogen /CO2/O2; sampling plan, locations, volumes, media, incubation, alert/action management and review all the test parameters.
• To review the Water chemical and Microbial analysis data in LIMS/ non-LIMS.
• BET (Bacterial Endotoxin Testing): Review and approval of gel‑clot /turbidimetric /chromogenic test reports; validation status, standard curves, inhibition/enhancement; Nexus‑200 setup and audit trail review for KTA instrument.
• Sterility: To perform verification of sterility test tubes and review of sterility test data.
• CCIT (microbiology‑relevant aspects): review of protocol/report linkage where applicable (e.g., microbial ingress risk assessments).
• Environmental Monitoring (EM) in LIMS: Perform plates/swabs verification for active air, settle plates, surface/contact plates, personnel monitoring; map locations, frequencies, routes, recovery rates, organism ID.

1. Verify acceptance criteria per specification/SOP/STP; ensure calculation accuracy and traceable raw data (plates, colony counts, instrument outputs, metadata).
2. Review of daily calibration/verification and audit trails of Microbiology Instruments.
3. Review of Temperature monitoring data of incubators/walk in Chambers.
4. Review of Non-Viable Particle count Monitoring Data in LIMS/ Non-LIMS.
5. Review of all Microbiology related SOP’s, protocol and summary reports.
6. To support Microbiology or other Cross functional teams during qualification/ re-qualification of facilities and utilities.
7. To Ensure the Microbiology function is consistently prepared for regulatory and customer inspections, and actively contribute in inspections involving microbiology‑related areas. To represent Microbiology Quality Assurance during (Internal/External) audits.
8. Escalate issues/concerns, w.r.t. non-compliance observed during review/approval and during QC Micro lab/ manufacturing Gemba walk rounds in a timely manner.
9. To involve in the investigations of deviations/ OOS/OOT/ incidents and facilitate closure of QMS elements such as CAPA, OOS, OOT, OOL, deviations and change controls associated with Microbiology.

Secondary Responsibilities:

1. To ensure compliance in media, culture and other reagent management in Microbiology laboratory with respect to inventory, consumption and regulatory requirement.
2. To review and approve Batch Analytical Records (BAR) associated with products, media fill or other PPQ batches.
3. To provide all the Microbiology related data required in Master batch Record or any associated records.
4. Review of Microbial trends for Environmental monitoring, Utilities (Water and process gases), NVPC, Product bioburden or any other Microbial trends like Annual Product quality Review, PPQ batches data, etc.
5. To facilitate effective closure of investigations pertaining to Microbiology, sample receipt and cleaning sections i.e. ensure that such investigations are conducted as per scientific rationale and cGMP regulations.
6. BAR review and support batch release.
7. LIMS support in static data and master data review and authorization.
8. OPVM data review and scheduler data review and authorization.
9. Perform periodic review of record sheets and logbooks for ALCOA+++ compliance.
10. Review EM, Utilities, and Product trends per frequency and detect special‑cause variations; recommend actions (expanded monitoring, limit re‑evaluation).
11. Maintain QA dashboards for RFT, on‑time approvals, recurrence, trend signals, DI findings
12. To perform additional responsibilities assigned by the L+1.

Qualifications

Educational qualification: M.Sc. in Microbiology or Biotechnology as major preferred

Work experience: 4+ 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

About the Department
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/#!/