Mohammed Alotaibi

• Managing all technical activites and ensuring it’s operating according to cGMP and SFDA requirement
• Preparation and Review of Investigation of Deviation/Market Complaints/Out of Specification/Product Recalls and Returned Product
• Ensuring the availability of adequate competent resources in the departments
• Review of Instrument/Equipment Qualification i.e. DQ, IQ, OQ and PQ.
• Monitoring and verification of the activity in shop floor l.e. dispensing, manufacturing, filling, packing, cleaning, data recording, inspection, environmental monitoring (temperature, humidity, pressure differential, non-viable & viable count
• Achieve Quality Assurance operational objective by contributing information and analyzing strategic plans, preparing and completing action plan, identifying and resolving problems completing audits and determining system Improvements
• Review of standard operating procedure(s). Ensure that SOPs are prepared & Implemented that meets cGMP, cGxP, regulatory standards and in-house requirements
• Controlling of Issuance and Retrieval of documents/formats/Specifications/ SOPs/Batch manufacturing Records (BMR) and Batch packing records (BPR) and Protocols
• Issuance and retrieval of documents/formats, form, Logbooks and other documents
• Ensuring of entry and exit procedure, gowning procedure, personal hygiene, safety and cleanliness as per SOP and cGMP regulation
• Verification of all the documents (Batch Records, Log books, Register, Formats etc...) used in all departments for online data recording and Good Documentation Practice
• Sampling of Bulk, finished product, retention sample.
• In-process sampling and Checks during manufacturing, filling and packing as per BMR and SOP
• Line clearance for dispensing, manufacturing, filling and packing activity
• Review of batch records and log books for its completeness and correctness as well as batch reconciliation and actual yield
• Responsible for implementation and compliance of Quality Management System (Change Control/Deviation/ OOS/ Investigation/CAPA) and PQR at site.

• Perform microbiological testing of raw material, packaging material, in-process sample and finished products
• Perform microbiological limit testing for stability study as per required specification
• Detail training on SOPs, standard test procedure for microbial test, sterilization process and preparation of report as per related SOP
• Brief training on handling of instrument such as
• Biosafety cabinet, pH meter, Weighing Balance and
• Autoclave
• To keep management updated on issues arising within the laboratory
• Handling American Type Culture Collection (ATCC) culture such as Escherichia coli , Pseudomonas aeruginosa ,Staphylococcus aureus , Candida , and Aspergillus
• Actively participated in sampling such as water and cleaning validation sample
• Perform water analysis by membrane filtration technique for total count and pathogen
• Antibiotic sensitivity test

RESEARCH PROJECTS :

Pseudomonas aeruginosa: an antibiotic resilient
pathogen from hookah water