Quality Control Microbiologist (QC Microbiologist)
National pharmaceuticals Factory
مجموع سنوات الخبرة :17 years, 7 أشهر
July 2015 till Present—National Pharmaceuticals Factory Co, Ltd, Riyadh, Saudi Arabia
(ISO 9001-2015, ISO 22716 2007 GMP ISO 13485 2016 and SFDA certified company)
Designation: QA/QC Senior Microbiologist
Job responsibilities include
1.Proficient in Microbiological analysis of various semisolid and liquid dosage products, like cosmetics products, cream, ointments based on General test Procedure and Pharmacoepial procedure USP & BP.
2. Performs microbiological analysis of raw materials, Packaging material, In-process samples finished products and purified water, .
3. Performs growth promotion testing for incoming growth media.
4.Environmental monitoring of classified clean rooms during manufacturing operations and routine modes for the presence of viable and non-viable particulates.
5.Participate in cross-training to support staff availability within QA/QC department.
Preparation of SOPS, Raw material and Packaging material Specifications, general test procedure, Standard test procedure, In-process test procedures as per requirement.
Efficacy of disinfectant study on disinfectants.
6.Assist in Cleaning validation, water validation and process validation study.
7.Assists in bringing in additional testing capabilities to the microbiology and Chemical lab as deemed necessary.
8.Perform stability studies on all finished product and preparation of analytical reports.
9.Preparing quotation analysis, purchase request in accordance to purchase of laboratory chemicals, glassware's, instruments and consumable's based on user requirement specification.
10.Assists in Preparation of BOM-Bill of material for procurement.
Assists in Documentation work related to 11.Quality assurance like Change control, preplanned deviation, incident report, CAPA, reviewing of BMR and BPR.
Preparing the Batch release certificate and Certificate of Analysis (COA).
12.Assist in preparing Management review meeting Minute, GMP review meeting Minutes, etc.
13.Assisting Quality assurance Manager work to complete the task as and when required.
Preparing of quality control Analytical reports for finished product and analytical reports for raw material.
14.Assist in conducting internal audit and audit schedule.
15.Assist in completing the task of QA/QC department.
16.Assist in giving line clearance to production and packaging department in absence of QA personnel.
17.Assist in preparing trend analysis for water and Finished products Parameters.
18.Assist in preparing OOS (Out of Specification) results and report.
Preparation and reviewing of SOPs to all other departments.
19.Preparing the documents for ISO 17025, ISO 9001-2015 ISO 13485 2016 and ISO 22715 2007.
MAY 2010 till date\]-ABC Techno labs India Pvt ltd, Chennai
(ISO 9000, 14000, 18000, &NABL Accredited laboratory)
Designation: Senior Microbiologist
JUNE 2008-MAY 2010- Blue water foods and exports Pvt ltd Mangalore (An ISO 22000 and BRC certified & EIA Approved company)
Designation: Microbiologist/ EIA Approved Technologist.
JULY 2006- JUNE 2008-Tuv-sud South Asia, Bangalore
(NABL, ISO, EIC Accredited laboratory)
Designation: Analyst
•✈ MASTERS IN MICROBIOLOGY - MYSORE UNIVERSITY - JUNE 2006
•☼ BACHALOR OF SCIENCE (BOTANY, MICROBIOLOGY & BIOCHEMISTRY) - MYSORE UNIVERSITY - JUNE 2004
