Assistant Manager QC/R&D
SAMI Pharmaceuticals
مجموع سنوات الخبرة :10 years, 1 أشهر
Major Responsibilities:
To Supervise Analytical Method Validation teams for smooth testing and reporting of validation of analytical methods to shift from non-pharmacopeia methods to pharmacopeia and Optimization of methods to lab environment.
To Supervise Trial & Development and Analytical Method Development Team for smooth testing and to develop methods to shift from non pharmacopeia methods to pharmacopeia and
Optimization of methods to lab environment.
To Supervise Comparative Dissolution Profile and Pharmaceutical Equivalence Studies between RLD and test product to evaluate similarity for BE purpose and for product dossier in regulated markets and local product launch DRAP.
To Supervise Compliance against ISO/WHO and PIC’s guidelines for Data Integrity, Data Traceability, Qualification and Calibration of Lab
and Laboratory equipment’s.
To Perform Cleaning Validation to evaluate effective cleaning procedure and reduce risk of cross contaminations.
To Perform Dose Solubility Studies and Solution Stability to evaluate sink conditions and degradation.
Standardization of working standards against Pharmacopeia and Manufacturers Reference Standards.
Calibration/Performance Qualification of Lab Instruments: pH Meter, Conductivity Meter, Electronic Weight balance, Dissolution
Apparatus, HPLC. Training on Different SOPs, QMS System, Guidelines and different
studies to team.
• Raw Material Testing of API to evaluate its Physical and Chemical properties and Vendor Management through Change Alert and Risk Assessment.
• Analytical Method Development to shift from non-pharmacopeia methods to pharmacopeia and Optimization of methods to lab environment.
• Comparative Dissolution Profile and Pharmaceutical Equivalence Studies between RLD and test product to evaluate similarity for BE purpose and for product dossier in regulated markets and local product launch DRAP.
• Validation/Verification of API and Finished Product for method Linearity, Repeatability, Accuracy, Robustness and to establish LOD and LOQ Levels
• Stability of Finished Product on several intervals for both accelerated and RT to interpolate shelf life of product and to evaluate product safety and efficacy throughout its shelf life.
• To Perform Particle Size Analysis and limit establishment of particle size because particle size is a major factor in dissolution release profile
• To Perform Dose Solubility Studies and Solution Stability to evaluate sink conditions and degradation.
• Train and supervise new analyst
• Standardization of working standards against Pharmacopeial and Manufacturers Reference Standards
• Calibration of Lab Instruments: pH Meter, Conductivity Meter, Electronic Weight balance, Dissolution Apparatus, HPLC
• CDP(Comparative Dissolution Profile) according to WHO Guideline TRS 937
• PE(Pharmaceutical Equivalance ) Study
• Worked on HPLC Agilent/Shimadzu, Spectrophotometer, Tintometer, Karl Fisher Water Conter, Auto Titrator, Potentiometer, FTIR, Polarimeter, Particle Size Analyzer, Dissolution Apparatus.
• Raw Material Testing:
Assay on Potentiometer/HPLC, Water Content on Karl Fischer /LOD on Moisture Analyzer, Identification on FTIR/UV, Optical Rotation/Specific Optical Rotation on Polarimeter, Particle Size on PSD Analyzer
• Calibration of Lab Instruments:
pH Meter, Conductivity Meter, Electronic Weight balance, Dissolution Apparatus.
Currently working in Tufail Chemical Industries as QC-Chemist since August 2014. My Responsibilities include
Preparation and Standardization of Standard & Working Solutions.
Calibration of Lab Instruments like: pH Meter S-20, TDS Meter S-30, Lovibond Tintometer PFX-195, Karl Fischer Auto-titrator T-50, Electronic Weight balance
Raw Material Testing include : (1) Sulphur: Purity, Ash, Moisture (2) Sodium Formate: Purity, Ash, Moisture (3)LAB: Moisture, Specific Gravity, (4)Ethoxylated Alcohol : Moisture, PEG Content
In-Process Testing include: (1) LABSA: Acid Value, Klett Color (2)SLES: pH, Acid Value, Active Matter, (3) Formic Acid: Purity
Product Testing include : (1)LABSA: Acid Value, Active Matter, Free Oil, H2SO4 Content, Klett Color (2)SLES: Acid Value, pH, Active Matter, Klett Color, Na2SO4 Content, Iron content, (3)H2SO4: Purity, Iron Content, (4)Formic Acid: Purity, Iron, Sulphate, Chloride, (5) Na2SO4 : Bulk Density, pH, Hardness, Moisture, Purity
Preparation of Process Sheets, COA(Certificate of Analysis) & DQR(Daily Quality Report).
Instruments worked and trained on (1)Lovibond Tintometer PFX195, (2)Karl-Fischer Auto-Titrator T-50, Karl-Fischer Volumetric Titrator V-20 (Water Content Determination), Spectrophotometer shimadzu UV-1800.
Pak Petrochemical is one of the leading PolyStyrene(PS) resin manufacturer in Pakistan. Pak Petrochemical produces three grades of PolyStyrene(PS) which are further classified according to their characteristics.They are
(I)General Purpose PolyStyrene(GPPS)
(II)High Impact PolyStyrene(HIPS)
(III)Expandable PolyStyrene(EPS)
At Pak Petrochemical during my internship i have learned about the manufacturing processes of the following types of Polystyrene:
(1)General Purpose Polystyrene( By Solution Polymerization)
(2)High Impact Polystyrene( By Solution Polymerization)
(3)Expandable Polystyrene( By Suspension Polymerization)
• Learned about different grades of Polystyrene that are GPPS, HIPS and EPS.
• Perform several physical and chemical tests of all mentioned grades of Polystyrene in Quality Control Lab like Tensile strength, Melt Flow Index, Free monomer & etc
Conducted various analytical jobs under the supervision of Scientific Staff.
Learnt the operation and handling of latest lab equipments Flame Photometer, Kjeldahl Apparatus, UV Spectrophotometer, Falling Number Apparatus, Refractometer, Soxhlet Apparatus, Conductivity Meter, Rotary Evaporator
Conducted testing of more than 56 Food Products during training
During training I have performed various analysis like Proximate Composition Analysis, Analysis of Vitamins (Water Soluble and Fat Soluble), Mineral Profile Analysis, Fatty Acid Profile, Heavy Metal Testing, Gum Base Estimation, Analysis of Sugar Testing (Basic & Advance), Analysis of Fruit / Fruit Products, Analysis of Additives & Preservatives
As student of MSc final year in Applied Chemistry i am learning about Analytical Techniques (Spectroscopy, Chromatography, etc) Chemical Reaction Engineering (Reactor designing). Petroleum , Petroleum Exploration, Composition & Petroleum Refining Processes , Catalytic Reforming ,Steam Reforming. Perform several tests in laboratory includes Water Testing ( pH ,TDS , SS , Hardness(Sulphates , Chlorides)) Textile ( Desizing, Scouring , Bleaching , Dyeing) Crude Oil & Lube Oil Tests includes Acid No# , ASH , Cloud Point ,Colour Saybolt ,Colour ASTM D 1500 ,Con Carbon residue, Distillation,Flash Point, Mercaptan Sulpher, , Pour Point, Specific Gravity, Sulpher Total, Viscosity , All tests are performed according To ASTM Standards
