Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
Role Summary:
To conduct routine and non-routine microbiological analysis of water sample, bulk & intermediate product. to Perform Environmental Monitoring of sterile area (aseptic) of the plant & to ensure cGMP, GLP and GDP compliance in Microbiology lab.
Responsibilities:
- To receipt and log the sample detail in relevant logbook & perform microbiological testing of bulk, & intermediate as per defined procedures and test methods.
- To report the results in time for review.
- To perform sampling and testing of Water for Pharmaceutical Usages, Water for Injection, final rinse water, manufacturing water, tap water, and feed water / drinking water and report the result in time.
- To perform Bacterial Endotoxin Test on Water for Injection, or wherever applicable.
- To perform the environmental monitoring of sterile areas, preparation and observation of results along with reports.
- To perform sterilization of media and media growth promotion test, maintain the record in time as per define procedure.
- To perform sub-culturing and prepare culture(s) suspension of microorganisms as per applicable procedures and maintain the records.
- To prepare the disinfectants as per applicable define procedures and maintain the records.
- To monitor & record RMS data for temperature and humidity of microbiology area / Incubators and refrigerators.
- To perform the identification tests of microbiological cultures and Isolates.
- To involve the samples / cultures transportation between laboratories.
- To maintain logbooks and records of all lab activities for compliance.
- To inform immediately any deviations, OOT, OOS and non-conformance to supervisor / Manager.
- To perform tests for water system validation and media fill trials as per validation protocol.
- To prepare and control Microbiology lab reagents and solution as per applicable SOP.
- To maintain lab equipment/instruments as per applicable procedure.
- New Logbook requisition as when required and its review.
- Preparation of reagent, solvent, solution, verification of QC instruments.
- Perform the QC in process Test for Ophthalmic Solution & Suspension.
- Preparation and readiness for compliance to various regulatory audits.
Qualifications:
- Fresh graduate up to one year of experience in pharmaceutical / food microbiological analyses and quality control.
- Bachelor’s or Master’s degree in Microbiology / Biochemistry
- Data analysis and good observation capabilities.
- Target oriented.
