Test Raw Materials
Resume:
AKASH BABBER
Pharmaceutical Microbiologist
Galpha laboratories
******.*****@*****.***
akash.babber
Career Objective
To attain a challenging position where I can utilize my experience and skills and creatively involved with systems that effectively contribute to the growth of organization. Educational Qualification
M.Sc in Microbiology from University of Jammu, J&K (2008).
B.Sc from University, J&K, (2006).
Professional Certification
FDA approved Chemist and Microbiologist in Cosmetics.
Approved Microbiologist from SFDA.
Environmental Management System ISO 14001: 2004 (Saudi Arabia)
Personal development course (Saudi Arabia)
Certificate for Food Quality and Management system (2016). Industrial Experience Summary
Well versed with all microbiological techniques related to oral dosage formulation and injectables manufacturing plant including cGMP, GLP, GDP and analysis of various environmental samples including potable and waste water. Work Experience – Present
Galpha laboratories limited (Alkem Group of Companies) www.galpha.com
Manufacture of tablets, capsule and oral liquids and multi vitamins. Baddi (Himachal Pradesh)
Position: - Senior Executive (Micro)
Jan 2018 to present
Responsibilities
Overall planning and monitoring of microbiology lab as section in charge.
Monitoring and reviewing of all type of microbiological analysis and data generated.
Preparation, updating and review of Standard Operating Procedures, Standard Test Procedures.
Maintaining laboratory inventory controls, base level, follow up, communicating with external parties for purchase of new equipments and indents.
Drain point analysis.
To ensure strict execution of validation protocols and preparation of protocols.
Validation of preservative efficacy test.
Vitamin B12 analysis and antibiotic assay.
Validation of microbial limit test.
Validation of swab recovery test.
To ensure that sops are strictly followed in laboratory and are in compliance.
Responsible for analyst follow up, releases, reviewing reports of MLT, Bioassay of finished products, Raw materials and in process samples. Page 2 of 4
Investigation of Out Of Specification Results (OOS), handling change controls and deviations.
Reviewing trends of Environmental Monitoring, Water samples.
Leading team during audits.
Previous experience
RIYADH PHARMA, formulation unit Approved by WHO, SFDA & GCC-CDR (Saudi Arabia) www.riyadhharma.com
Pharmaceutical manufacturing company in Saudi Arabia. Manufactures tablets, syrups, capsules, eye drops and ointments, and skin care creams and ointments. Contracted by Saudi Geophysical consulting office, al -khobar (Saudi Arabia). Position: - Senior Microbiologist
Aug 2016 to December 2017
Responsibilities
Member of Environmental Management team for Royal Commission, KSA
Conducting training for analysts for recent developments, revisions in microbiology, CGMP and CGLP.
Preparation, updating and review of Standard Operating Procedures, Standard Test Procedures.
Responsible for analyst follow up, releases, reviewing reports of sterility, MLT, Bioassay and Endotoxin Test of finished products, Raw materials and in process samples.
Organizing and performing media fill activities for all the lines of aseptic manufacturing.
Microbial identification using Rapid Microbial Identification System (Vitek-MS - V3, Biomerieux).
Investigation of Out Of Specification Results (OOS), handling change controls and deviations.
Reviewing trends of Environmental Monitoring, Water, finished products and raw materials on monthly basis.
Operation and calibration of TOC analyzer (TOC torch -Teledyne tekmar).
LAL Test "Bacterial Endotoxin test, Growth Promotion Test.
Validation (biological Assay, Sterility Test and Cleaning Validation)
Environmental monitoring of clean and classified areas by Settle Plate, Air Sampling, and Contact Plate methods.
Operation, calibration of BX53 Olympus microscope.
Maintaining laboratory inventory controls, base level, follow up, communicating with external parties for purchase of new equipments and indents.
Hand on experience in LIMS and SAP (centralized ERP) and Open cfu software. Julphar life, Oral Dosage formulation and Parenterals Unit (Approved by MOH, GCC-CDR WHO & cGMP)
www.julphar.net
Dubai Healthcare City, (UAE)
Company profile Julphar is the largest generic pharmaceutical manufacturer in MENA. Julphar works closely with regulatory bodies, such as the UAE Ministry of Health (MOH) and the US Food and Drug Administration (FDA) to ensure all our practices are aligned with the international requirements. Parenterals, capsules, liquids and dry syrups. Contracted by Saudi Geophysical consulting office, al -khobar (Saudi Arabia). Position: - Senior Microbiologist
May 2014 to June 2016
Page 3 of 4
Responsibilities
Perform microbiological test (limit test of raw material and finish products, Bioassay, Preservative Efficacy test, Growth Promotion test, ATCC culture maintenance).
Microbial identification using API Kits (20E & 20C).
BET (Bacterial Endotoxin Test, Gel clot assay).
Sterility test (Membrane Filtration Method).
Assay of antibiotics.
Perform schedule monitoring of water, RO plant, and production environment.
Conducted Proficiency Test for HPC and Coliforms, TOC following standard method.
Microbiological environmental monitoring of clean classified areas by Settle Plate, Air Sampling, and Contact Plate methods.
Ensure the smooth operation, calibration and validation of Microbiology equipments.
To ensure the quick and accurate collection of sample of packaging components, raw materials and finished products before analysis and issuing the release, reject & quarantined advice related with microbiological criteria.
Preparation of SOP of raw materials, finished goods, packing materials and equipments of Microbiology lab.
Monitoring of waste disposal into the Microbiology lab (Including hazardous waste).
Assist with audits, OOS investigations, document control, and change control. Sun Pharma, Formulation Unit (Approved by WHO & cGMP) www.sunpharma.com
Jammu and Kashmir, (INDIA)
Company profile
Sun Pharma is one of the top pharmaceutical companies in India and is involved in the manufacturing of Anti-retroviral (ARVs), Active Pharmaceutical Ingredients (APIs) and intermediates in the full range of dosage forms, including tablets, capsules, injectables, ointments, creams and liquids. Sun Pharma also manufacture speciality APIs, including controlled substances, steroids, peptides and anti-cancers. Position: - Senior Microbiologist
Dec 2010 to April 2014
Responsibilities
Microbial analysis of various Raw materials.
Microbial analysis of various Pharmaceutical finished products
Sampling and Microbial analysis of Raw and Potable water and Purified water.
Biochemical identification of bacterial and fungal isolates from raw and finished products
Microbiological environmental monitoring of clean classified areas by Settle Plate, Air Sampling, and Contact Plate methods.
Preparing and updating QC related SOPs and analytical Data Sheets.
Assay of Probiotics.
Assay of Vitamin B12.
Operation, calibration and validation of Autoclave.
Operation and calibration of TOC analyzer TOC-VCSH shimadzu.
Involved in analysis of water samples using Spectrometer, Ion Chromatograph, FT-IR and other lab inst’s
GPT, PET and Disinfectant validation and analysis.
Maintenance of Strain - Revival of freeze Dried culture.
Preparation of Stock and Working culture.
Basic knowledge in ICH guidelines, 21 CFR 211 & 210. Page 4 of 4
Basic Knowledge of ERP and LIMS.
Introduction to HACCP.
Anphar Organics, Formulation Unit (Approved by WHO & GMP) Jammu and Kashmir (INDIA)
www.anphar.com
Position: -Trainee Microbiologist
February 2010 to October 2010
Job Profile
Microbial analysis of various Raw material and Finished products.
Sampling of Water, Raw and finished product.
Microbial analysis of Raw and Potable water and Purified water.
Biochemical identification of bacterial and fungal isolates.
Media preparation for routine analysis of samples.
Chemical analysis of various types of water samples.
Preparation and standardization of reagents of routine analysis. Personal details
Father’s Name: K.L. BABBER
Permanent Address: 171/13 NANAK NAGAR
JAMMU – 180004
J & K State, India.
Mobile: +917*********
Passport details: J3195795, Expired on Feb 2021
Date of birth: 11th May, 1984.
Sex: Male.
Nationality: Indian.
Languages: English and Hindi.
Marital status: Unmarried.
Driving license: KSA, Dubai
Transferable Iqama: 236-***-****
DECLERATION
I solemnly declare that the above information is true and correct to the best of my knowledge. I understand that if any information given above is found false/incorrect, my candidature is liable to be rejected.
Place: (Akash Babber)
Date: Signature
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