Specialist - Quality Control (Micro)

2 weeks ago

Singapore Pharmagend Global Medical Services Pte Ltd Full time

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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