Summary
Overview
Work History
Education
Skills
Personal Information
Projects
Disclaimer
Certification
Timeline
Generic

SABER AHMED KHAN

CHENNAI,KA

Summary

Regulatory Pharmaceutical Microbiologist with 11 years of experience in Q.C. Microbiology Laboratory. Completed (ISO 22000:2018, ISO 19011:20218 & FSSAI) Certification Courses with the Awareness Training on GSO2055-II:2021. Work for Quality Control of High Market Valued Products for Example, Sterile, Non-sterile (Solid & Liquid), Medical Devices, Ointments and Biotechnology. I had the Opportunity to Work with Different Multinationals and to Manage Teams in Different Countries with Diverse Backgrounds and cultures (India (Daman, Vapi, Tamil Nadu), China (Beijing & Guangzhou), and KSA). Currently Working as a TAD Manager/Lead Auditor in HALAL INDIA PVT.LTD. Manage Teams and Working in a Team also Sharing Knowledge with Team and Learn New Standards E.g. GSO, SMAIIC, ISO, MS etc. to Fulfill HALAL International Requirements. I am Keen to join a Successful and Dynamic Organization that will Challenge my Problem-solving Skills and allow me to help in the Growth and Development of Organization & Myself.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Technical Assessment Department Manager Cum Technical Auditor & Halal Compliance

HALAL INDIA PVT. LTD.
03.2022 - Current
  • Help to Complete Documentation of Regulatory Accreditation like (ISO, GAC, MS, BPJHP etc.)
  • Prepared Standard operating procedures and Halal India policies as per ISO, GSO, MS & BPJHP Requirements
  • Performed around 150 Audits (Chemicals, Pharmaceuticals, Bio-pharmaceuticals, Nutraceutical, Cosmetics and Foods etc.)
  • (HIPL Accredited from GSO 14-07-2023 & BPJPH (Indonesia) - 01-04-2024) Self-assessment of Renewal, Product Addition and New Queries, also made changes in certification as requested
  • Help HIPL for different Certification E.g
  • Non-GMO, GVCS, Organic, Gluten Free Certification etc
  • Management and Implementation of Documents as per GSO, ISO, MS & BPJHP Requirements
  • Handling Domestic and International Client Queries with Analytical Thinking, Politeness & Professionally
  • Handling Regulatory Queries like THIDAS, GSO, MS, BPJPH and International Certification Bodies etc
  • Brings all Teams under One roof to complete task in time, Arrangement of TAD team Meetings, Trainings & Manage Team Work Allocation
  • Maintain All Annual, Monthly & Weekly Renewal, Product Addition & New Queries Report
  • Support Continuous Improvement Initiatives

QC SENIOR ENGINEER INSPECTOR SBJECT MATTER EXPERT

BIO-THERA SOLUTIONS, LTD.
12.2019 - 12.2021
  • Reporting to Quality Head, Preparing Microbiology Lab for EMA and USFDA Support Continuous Improvement Initiatives Revised Procedure as per EMA and USFDA Guidelines Write and/or Review Documents like SOPs, Validation Protocols, IQ, OQ, PQ and DQ Method Development (Sterility Test and MLT Test) Perform ELISA Test (Host Cell Protein & Protein-A) Perform All Microbiological Analysis Including Sterility, MLT test and Method Validation etc
  • Regulatory Guideline Training to QC Department Water System Validation

LABORATORY INCHARG–GLP & QUALITY DOCUMENTATION

AVALON PHARMACEUTICLAS LTD.
12.2017 - 12.2018
  • Performed Internal Audit as per ISO 9001 (QMS)
  • Review of Microbiology Documents before submission to Regulatory Bodies Training to Microbiology, Production and Sampling Department Preform Microbial Limit Test of All Samples FP, PM, RM, IP etc
  • Environment Monitoring (Active, Passive Air Sampling and Contact Plate Monitoring) Execute Activities Like Design of Experiment for New Products Perform Growth Promotion Test of Media OOS and Deviation Handling Preparing Environment as well as Water Trend

INSPECTOR MICROBIOLOGIST–VALIDATION INCHARGE, GLP AND DOCUMENTATION

BEIJING SCIECURE PHARMACEUTICAL
11.2013 - 11.2017
  • Passed MHRA in 2016 Passed USFDA in 2017 Submitted Microbiology Documents for Regulatory Audits Pure Culture Maintenance Using Freezing Tubes

EXECUTIVE– VALIDATION AND DOCUMENTATION

MERIL LIFE SCIENCES PVT LTD
11.2013 - 11.2014
  • Passed Audit ISO, CE Marking and WHO in 2014 Protocol Preparation and Execution (Sterility & MLT) etc
  • New Clean Area Validation
  • Performed Bioburden & Sterility Test of Medical Devices
  • Performed Method Validation of Sterility Test

ASSISTANT SUPERVISOR

MEDLEY PHARMACEUTICALS LTD.
08.2010 - 10.2013
  • Autoclave Validation
  • Water System Validation
  • MLT Method Validation
  • Gown Validation
  • Area Validation
  • Disinfectant Validation
  • Document Preparation like SOPs, Protocols etc

Education

MASTER OF SCIENCE (M.Sc. – MICROBIOLOGY) -

SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY
NANDED, MAHARASHTRA
07.2010

BACHELOR OF SCIENCE (B.Sc.) -

SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY
NANDED, MAHARASHTRA
06.2008

Skills

  • Time Management & Analytical thinking
  • Problem Solving Ability, Commit-mating, Fast Learner, Smart as Well as Hard Working Skill
  • Instrument Knowledge: Microscope, Autoclave, Laminar Air Flow, Colony Counter, Isolator etc
  • Excellent Written and Verbal Communication Skills
  • Always Update VMR (View My Records) and push client files to Team and updated
  • Strong Team Working Skills & Good Decision Making, Planning, Coordination and Supervision Skills
  • Good Leadership, Organization and Coordination Skills, Strong Ability to Judge, Analyze and Solve Problems
  • Language Skills: English, Hindi, Urdu, Marathi, Chinese (Beginner)

Personal Information

  • Passport Number: U 09 9 25 5 0
  • Title: Microbiologist
  • Date of Birth: 10/22/1986
  • Nationality: INDIAN
  • Marital Status: MARRIED

Projects

Assisting QA for Shipping Validation and Related EMA Guideline Self-inspection of Bio-Thera (Manufacturing, QC, QMS, Utility etc.) Assisting Regulatory Head for EUQP Guideline and Selection of QP Assisting EMA/USFDA Auditors in QC Inspection New Lab Maintains in Medley and Beijing Sciecure Pharmaceuticals & Bio-thera Solutions Pvt Ltd. Vendor Audit (Ready to Use Media and Ready to Use Sterile Glassware’s)

Disclaimer

I hereby declared that the above information are true and correct.

Certification

ISO 22000 : 2018

ISO 19011 : 2018

FSSAI

Awareness Training on GSO2055-II : 2021

Timeline

Technical Assessment Department Manager Cum Technical Auditor & Halal Compliance

HALAL INDIA PVT. LTD.
03.2022 - Current

QC SENIOR ENGINEER INSPECTOR SBJECT MATTER EXPERT

BIO-THERA SOLUTIONS, LTD.
12.2019 - 12.2021

LABORATORY INCHARG–GLP & QUALITY DOCUMENTATION

AVALON PHARMACEUTICLAS LTD.
12.2017 - 12.2018

INSPECTOR MICROBIOLOGIST–VALIDATION INCHARGE, GLP AND DOCUMENTATION

BEIJING SCIECURE PHARMACEUTICAL
11.2013 - 11.2017

EXECUTIVE– VALIDATION AND DOCUMENTATION

MERIL LIFE SCIENCES PVT LTD
11.2013 - 11.2014

ASSISTANT SUPERVISOR

MEDLEY PHARMACEUTICALS LTD.
08.2010 - 10.2013

MASTER OF SCIENCE (M.Sc. – MICROBIOLOGY) -

SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY

BACHELOR OF SCIENCE (B.Sc.) -

SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY
SABER AHMED KHAN