Microbiology Lab Analyst

2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full time

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Carry out microbiological analysis of samples taken from raw materials, semi-finished and finished products, raw/purified water used in the plant, plant environment, air, surfaces and employees, prepare culture media, ensure proper documentation of all activities, calculations and results according to SOPs and approved forms maintaining compliance with cGMP and GLP.

Duties and Responsibilities:

  • Adhere to the current good manufacturing practices (cGMP) in all activities.
  • Carry out Microbial Limit Test for (finished products and raw materials) according to approved methods.
  • Carry out environmental monitoring for the microbiology lab. as per approved SOPs
  • Carry out microbial testing for the air in the production area and sampling room in warehouses.
  • Carry out microbial testing for compressed air.
  • Carry out microbial testing for the surface of production machines.
  • Carry out Personal Hygiene tests for production employees.
  • Carry out sampling, and testing for raw water, purified water and water purification unit.
  • Carry out Media preparation, quality testing and storage.
  • Carry out Quality control test, maintain and storage of reference strains (microorganisms).
  • Carry out the Preservative Efficacy Test for the required stability batches.
  • Carry out microbial testing for Primary Packaging materials and intermediate containers.
  • Monitor the temperate of instruments in Microbiology Laboratory (oven, water baths).
  • Carry out tests to evaluate lab. instruments performance (biological indicator, soft water )
  • Calibrate laboratory instruments according to approved SOPs.
  • Perform Microbiological, physical and chemical tests for E.H.G. capsules.
  • Prepare and sterilize reagents, solutions, tools and glassware needed for microbiological tests.
  • Identify and label all preparations, tools, media, etc. used in microbiology laboratory.
  • Record and document all activities using the designated logbooks and records to maintain traceability.
  • Reporting and documentation for tests results in an accurate and timely manner using approved forms.
  • Carry out OOS laboratory investigations and follow up of OOS reports.
  • Assist in handling deviations, investigations and CAPA requiring Microbiological input.
  • Ensure neatness of Microbiology Lab. and housekeeping.
  • Carry out decontamination of biohazards waste using the adopted system and approved SOPs.
  • Dispose of all waste products as per approved SOPs, ensuring adherence to Good Laboratory Practice.
  • Demonstrate excellent analytical skills, able to plan, organize and follow up work effectively while focusing on quality towards excellence.
  • Strong team player with excellent communication skills
  • Proactively take initiatives and demonstrate a dynamic approach to adapt with changing business needs and environment

Professional Knowledge:

  • Knowledge in the systems such as ICH, GMP, GLP, WHO
  • International and EU Regulations
  • Ministry of Health Regulations

Job Requirements:

  • BSc. Degree in Microbiology, Biology, Biotechnology, Medical Analysis or related fields.
  • 0 – 3 years of relevant experience.
  • Proficiency in written, read and spoken Arabic and English.
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