
Specialist - Quality Control (Micro)
4 days ago
KEY DUTIES AND RESPONSIBILITES:
- Responsible for the analysis of RM, finished product/in-process/stability/validation/utility samples for MLT by referring current version of specification/STP/SOP with relevant product code.
- Responsible for the analysis of water samples by referring current version of specification/STP/SOP with relevant code, based on of monthly schedule.
- Responsible for the analysis samples of EMP by referring current version of SOP.
- Perform identification of microorganism isolate by microscopy.
- Perform the assay test as per STP/SOP by Microbiological method.
- Check the sample integrity with respect to labelling, container, packing, time point, sampling point, etc., along with availability of reagent/chemical/media as per STP/SOP and within the validity.
- Preparation of all microbiological media/diluent/sample as per SOP/STP.
- Ensure maintenance, review and availability of media/cultures and miscellaneous materials.
- Ensure implementation of SOP for all corresponding activities.
- Write controlled documentation related to Microbiology Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
- Ensure real time documentation, maintain data integrity and appropriate traceability.
- Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
- Responsible for preventive maintenance and calibration of microbiological lab instrument.
- Responsible for microbiology lab and equipment/instrument cleanliness.
- Responsible for procuring and receipt of microbiology glassware and consumables.
- Preserve all sample media petri plates till the completion and confirmation of results.
- Responsible for disposition of samples upon confirmation.
- Any other activities as and when assigned by the Superior.
COMPLIANCE AND QUALITY:
- Good understanding of safe working practices and cGMP.
- A good team player with positive learning attitude.
- Microsoft savvy with good interpersonal skills.
EDUCATION & EXPERIENCE:
- Degree / Diploma in Science related discipline.
- Minimum 4 years of experience in a pharmaceutical environment.
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