Quality Assurance Associate Microbiology Reviewer

Team Member AQA 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 testlevel and samplelevel LIMS analytical data review and approval for:

• Bioburden/Inprocess: 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 gelclot /turbidimetric /chromogenic test reports; validation status standard curves inhibition/enhancement; Nexus200 setup and audit trail review for KTA instrument.
• Sterility: To perform verification of sterility test tubes and review of sterility test data.
• CCIT (microbiologyrelevant 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 SOPs 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 microbiologyrelated 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.

Qualifications :

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 specialcause variations; recommend actions (expanded monitoring limit reevaluation).

1. Maintain QA dashboards for RFT ontime approvals recurrence trend signals DI findings
2. To perform additional responsibilities assigned by the L1.

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