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
Hyderabad
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
Bangalore
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 Pradesh01.2007
Bachelor of Science - undefined
S K University
Anantapur, Andhra Pradesh01.2005
Skills
Instrument calibrations
Quality Assurance
Quality management system expertise
Preparation of Specification and STP
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