Summary
Overview
Work History
Education
Skills
ROLES AND RESPONSIBILITIES
Personal profile
Timeline
Generic

MAHAMMED RAFI

Assistant Manager-QC
Anantapur

Summary

Aiming to operate with an emerging organization and employ my analytical, experimental, innovative, and administration abilities, including my past comprehensive experience to reach the objectives of the organization.

Overview

14
14
years of professional experience
4
4
Languages

Work History

Quality Control

MSN laboratories Pvt Ltd
04.2018 - Current
  • Reviewed various documents, including calibration reports, preventive maintenance reports, daily verification records, deviations and OOS, ensuring compliance with quality standards and regulatory requirements.
  • Managed GLP, GDP, and regulatory compliances, actively participating in audits to ensure adherence to quality assurance protocols and industry standards.
  • Generated and implemented QC procedures and policies, ensuring standardized practices and maintaining a high level of quality assurance across processes.
  • Conducted mock laboratory audits regularly to ensure strict compliance with industry standards, updating SOPs, and test methods to meet GMP requirements.
  • Lead and participated in various audits, handling self-inspections for packaging development, raw material, and other plant areas, ensuring strict adherence to quality control measures.
  • Played a key role in LIMS validation for all modules and implemented caliber LIMS for a paperless laboratory, ensuring efficient management of master formulas, sample data, stability testing, and instrument records.
  • Demonstrated proficiency in SAP software, utilizing it for streamlined operations and effective coordination with production and warehouse teams.
  • Managed the calibration of various instruments, including UV/visible and IR spectrophotometers (Perkin Elmer, Shimadzu), HPLC and GC.
  • Demonstrated expertise in regulatory compliance, including cGMP, CSV, and FDA regulations, with a deep understanding of GAMP and 21 CFR part 11 standards, ensuring full compliance in all quality control processes.
  • Utilized extensive experience in formulation QC testing across various areas, such as raw materials (RM), Packaging material (PM), and calibrations.
  • Regulatory Compliance: In-depth understanding of regulatory standards, including cGMP, CSV, FDA regulations, GAMP, and 21 CFR part 11, ensuring all processes adhere to industry regulations.

Sr.Executive Analyst

Micro Labs Ltd
07.2011 - 03.2018
  • Company Overview: Sterile plant, Bangalore, India, an USFDA, MHRA & WHO Certified Company
  • Performed sampling and analysis of Raw and Packaging material.
  • Audit preparations.
  • Approving the artworks and handling of shade cards.
  • Conducting and initiating the training and analyst qualifications for new joined employees.
  • Reviewed documents, including calibration reports, preventive maintenance reports, and daily verification records.
  • Initiated, reviewed, and closed change controls through QMS.
  • Reviewed deviations, OOS documents.
  • Updated SOPs and test methods to meet GMP requirements.
  • Active role in harmonization of specification and STP of all Ajanta's plant.
  • Instruments Handled:
  • HPLC (Agilent-1200 & 1260) with Empower-3 Software
  • HPLC (Waters-Alliance 2695) with Empower-3 Software.
  • HPLC (Shimadzu) with Empower-3 Software
  • UV Spectrophotometer (Shimadzu) with UV Solutions Software.
  • FTIR (Shimadzu) with Lab solution Software.
  • FTIR (Perkin Elmer) with IR solution Software.
  • Polarimeter (Rudolph Analytical)
  • Tiamo (Auto titrator & KF)

Education

Master of Science - Microbiology

S K University
Anantapur, Andhra Pradesh
01.2007

Bachelor of Science - undefined

S K University
Anantapur, Andhra Pradesh
01.2005

Skills

Instrument calibrations

ROLES AND RESPONSIBILITIES

  • Planning analysis of API, Excipients in caliber LIMS
  • Receive and carry out the Analysis of Raw materials, Inprocess samples & Finished Products
  • Document Review and Management
  • Quality Control Process Management
  • Protocol Creation and Implementation
  • Audit and Compliance Management
  • LIMS and Software Expertise
  • Instrument Calibration and Testing
  • Regulatory Compliance and Training
  • Formulation QC Testing

Personal profile

  • Name: P. Mahammed Raffi.
  • Father’s Name: P. Hameed Khan.
  • Marital status: Married
  • Languages known: English, Hindi, Telugu & Kannada.
  • Nationality: Indian.
  • Permanent Address: Thimmapuram, Kambadur (M.D), Anantapur (DT), Andhra Pradesh

Timeline

Quality Control

MSN laboratories Pvt Ltd
04.2018 - Current

Sr.Executive Analyst

Micro Labs Ltd
07.2011 - 03.2018

Bachelor of Science - undefined

S K University

Master of Science - Microbiology

S K University

Similar Profiles

CREATE PROFILE
MAHAMMED RAFIAssistant Manager-QC