- Daily calibration of Equipment’s
- Daily Monitoring of cleaning and recoding the same.
- Water sampling and analysis as per the schedule.
- Environment monitoring of listed areas in lab and plant as per SOP.
- MLT of finished product as and when received for analysis.
- Update documents in raw data sheet for all analysis.
- Release of test reports to the concerned at the end of analysis.
- Zone of Inhibition testing for antibacterial projects at R&D (KRC &KBC).
- Antibacterial Efficacy studies of in-house /market formulation.
- Biochemical assay for irritation evaluation of formulated samples.
- Culture Maintenance and Sub culturing of Bacteriological and fungal cultures (Inoculated cultures using spreading, streaking and pour plate techniques)
- Growth Promotion Test for Culture Media, Environmental Monitoring, Sampling of Products- FG, RM, Testing of Disinfectant by Efficacy Test.
- Responsible for EMS and QMS activity.
- Preparation of QA SOPs and review of other department SOPs as and when required.
- Responsible for verification of packing records, labels, COAs, containers etc. for dispatch activity and maintaining the dispatch related documents.
- Ensuring the marketing samples are packed properly, labeled, COAs, container and it is delivered correctly to the marketing requirement based on the sample advice not/sample request and approval of COA.
- Responsible for Issuance/distribution of controlled documents of BPCRs/formats/log books/SOPs/protocols etc.
- Responsible for Filling customer questionnaires as and when required.
- Supporting regulatory/marketing/sales department as and when required.
- Reviewingand approval of analytical documents before batch release.
- Reviewing and approval of product dossiers.
- Coordinating with HR department for making annual training planner and conducting training programms as per schedule.
- Responsible for preparation of self-inspection schedule and coordinating with team for execution as per the schedule.
- Responsible for review and approval of Equipment/Instrument qualification.
- Responsible for all external audits (Customer, regulatory and ISO audits) as and when required.
- Handling of change control, deviation, market complaints, returned goods, product recall, self inspection and corrective and preventive actions.
- Responsible for daily monitoring of all department functions and record the observations and issuing of non confirmity to department.
- Responsible for review and approval of stability protocols and summary reports.
- Responsible and assure for follow up of individual department for calibration & preventive maintenance of laboratory equipment and laboratory instruments are conducted as per schedule.
- Responsible for applying drug licencees and supporting to maintains the legal documents properly.
- Approving all specifications and master production instructions, Test methods, Qualifications.
- Responsible for review and approval of executed BPCRs and equipment cleaning records.
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