Job Detail
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Job ID 8437
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Career Level Experienced Non-Manager
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Education Level Bachelor\'s DegreeMaster’s Degree or equivalent
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Industry Pharmaceutical
Job Description
- Prepares and reviews SOPs of Microbiology Department.
- Prepares all Specification, Standard Test Procedures and General Test Procedures of raw materials, packing materials and In-process / Finished products microbiological analysis.
- Training for Microbiology laboratory personnel.
- Evaluates and certifies analyst qualification of Microbiology laboratory personnel.
- Prepares and executes preventive maintenance schedules for the Microbiology instruments.
- Prepares and executes calibration schedules of Microbiology Department Instruments.
- Participates in the committee of IQ, OQ, PQ and external calibrations of all Microbiology department instruments as per the Schedules.
- Share with other section Heads in preparing, reviewing and executing protocols, worksheets and reports related to analytical method transfer activity for API and finished products.
- Validates methods according to the regulations of pharmaceutical industry started from preparing the protocol to the final report that summarizing the data.
- Responsible for cGMP compliance inside microbiological lab.
- Supervises Operation and calibration of Microbiology Department
Cleaning and sanitization of Microbiology laboratory.
- Supervises Handling, usage and purity check of microbial cultures as per the internal SOP.
- Supervises Testing of biological and chemical indicator used in the validation of sterilization equipment’s.
- Monitoring of microbiological environmental in manufacturing, microbiology lab areas, and personnel.
- Preparing and reviewing the trends of microbiological analysis results.
- Investigation of OOS and OOT in the Microbiology Department.
- Management of microbial cultures.
- Execution and reviewing of usage log books of Microbiology Department instruments.
- Represent QC Manager to follow up all activities related to Stability and Methodology Section
- Participate in determination safety risks and hazards in his section and arrange plans to control such risks
- Co-operation with EHS specialist to solve problems and any deficiency in the system if    present
- Performs Microbiological analysis of all samples (raw materials, packaging materials, in-process samples, finished products, water samples, or any other samples)
- Prepares calibration schedules of Microbiology Department Instruments.
- Operates and calibrates all Microbiology Department Instruments.
- Writes all Microbiology department analytical and calibration reports
- Any other additional responsibilities given by head of the department time to time.
Job Requirements:
- Certificate: Bachelor of pharmacy & Sciences
- Experience: (5-7) years
Job Authorities:
Authorized to perform the following:
- Preparation of specifications & GTPs & STPs and worksheets for Microbiological samples
- Review calibration of all microbiological lab instruments
- Training and qualification of all analysts in Microbiology section
Reporting to (Immediate Reporting boss):
Microbiology Head
Authorized Deputy (Responsible Person in case of his / her absence):
Microbiology Senior Analyst or Microbiology Analyst
Required skills
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