Pharmaceutical Quality Assurance Expert
2 weeks ago
The Quality Control Specialist (Micro) is a crucial role in ensuring the quality of products and services within a laboratory setting.
Key responsibilities include analyzing RM, finished product/in-process/stability/validation/utility samples for Microbiological Laboratory Testing (MLT), as per current version specifications/Standard Operating Procedures (SOPs)/Standard Technical Procedures (STPs). This involves referring to relevant product codes, performing identification of microorganism isolates by microscopy, and conducting assay tests according to STP/SOP using microbiological methods.
In addition, the incumbent will be responsible for checking sample integrity regarding labeling, containers, packing, time points, sampling points, etc., along with the availability of reagents/chemicals/media as per STP/SOP and within validity. Preparation of all microbiological media/diluent/samples will be done according to SOP/STP.
The successful candidate will also be responsible for maintaining, reviewing, and ensuring the availability of media/cultures and miscellaneous materials. Furthermore, they will ensure the implementation of SOPs for corresponding activities and write controlled documentation related to Microbiology Laboratory operations or testing such as SOPs, analytical protocols, analysis reports, and forms.
Effective communication and teamwork are essential skills required for this position. The ideal candidate will have a good understanding of safe working practices and cGMP, as well as excellent interpersonal skills. A degree/Diploma in a science-related discipline and at least 4 years of experience in a pharmaceutical environment are minimum requirements.
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Pharmaceutical Quality Assurance Specialist
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