Executive QA- Micro Lab

3 weeks ago

Jhagadia, India Abbott Laboratories Full time

Primary Function/Primary Goals/Objectives:
To conduct the Microbiological analysis for Raw Material, Packing Material, In-process product, Finished Product, Environmental Monitoring samples as per sampling plan and conduct the test according to AN/BIS methods and on time report the results.

Major Responsibilities:

- Responsible collect the ingradients, EMP, Packaging, in process samples and finished product samples as per sampling plan and conduct the test inline with AN methods.
- Responsible for analysis of all the BIS (Infant) products as per BIS methods and release the batches as per agreed SLAs.
- Responsible for preparation and sterilization microbiological media according to AN and BIS requirements.
- Conduct Microbial growth promotion testing as per AN method and record the results.
- Resonsible for Decontamination of Biohazard waste generated from micro lab.
- Responsible for conduct the routine calibration / Verification for glassware and equipments.
- Responsible for compositing the FP and RM as per method followed by GLP.
- Strictly follow the GDP requirements to avoid the errors during documentation.
- Maintain the 6S in Micro lab religiously.
- Responsible for Daily review Online Temperature monitoring system and associted Data.
- Maintain the raw data for all the test parmeters and record keeping.
- Follow the GHK practices in lab and monitor the routine cleaning practices.
- Any deviation observed like OOS, OAL immediately informed to Lab FLL or Lab Manager.
- Record keeping to be followed as per retention policy.
- Handling of additionals projects as per management directions.
- Complete the compliancewire training as per schedule.
- Review the methods and SOP on periodically as per schedule.
- Media and consumables tracking and inventory management.
- Rais the LIR against the OOS and handling of change control request as per QA system.
- Review of laboratory records.
- Responsible for handling of internal audits and track the CAPA.
- Responsible to attend the Tier 1 meeting on daily basis.
- Idea generation and implementation.

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