Experience

Phebra Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Analytical Method Development & Validation Specialist

  • Jul 2022 - Present

   Develop analytical methods in conjunction with the NPI team for identified Phebra products as per ICH guidelines and international regulatory standards.  Draft and execute analytical validation protocols for Phebra products as per ICH guidelines and international regulatory standards.  Draft analytical validation reports.  Assist in the coordination of method transfer from NPI to QC laboratories including assisting in the drafting of transfer protocols and subsequent execution.  Liaise with staff and troubleshoot analytical method related issues as part of ongoing CAPAs  Assist in OOS investigations where method development and validation are identified as potential root causes. Assist in the formulation of hypothesis testing where required.  Draft, review and update standard operating procedures pertinent to the role or as directed by the NPI Project Manager.  Train and develop staff in use of HPLC and method validation.  Purchase all necessary consumable items and reagents required to conduct method development and validation activities.  Perform analytical testing on products undergoing development.  Support the regulatory department with any submissions to national and international regulatory authorities regarding analytical method and validation.  Assist in the maintenance and calibration of NPI laboratory equipment as required as per Phebra procedures.  NPI system improvements when required as part of the continuous improvement Principles. Show less



Pax Australia Pty Ltd

• Australia
• Manufacturing
• 1 - 100 Employee

• Instrumentation Chemist (Shift In-Charge)

  • Nov 2020 - Jul 2022

   To manage all activities of Instrumentation testing in shift and make sure the compliance working throughout the shift.  Responsible for conducting laboratory testing such as Raw Materials, finished products and Stability Testing according to test procedures ensuring TGA, GMP and NATA compliance.  To perform Analytical Method Development & Analytical Method Validation for new and existing products.  To Perform Investigation studies of products having OOS/Atypical results and to prepare related documents and conduct the root cause analysis.  To perform Standardization of secondary standards through primary standards along with Certificate of Analysis traceability.  To Conduct troubleshooting of QC instruments such as HPLCs & GC.  To prepare and revise Standard operating procedures and testing methods.  Quality Control (QC) analysis of personal care and household liquids and aerosol products and Insecticides testing. Show less



Sphere Healthcare Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Analytical Chemist (HPLC Chemist)

  • Jan 2019 - Oct 2020

   Responsible for conducting laboratory testing such as Raw Materials, finished products and Stability Testing according to test procedures.  Involved in Analytical Method Validation and Analytical Method Development.  To Perform Investigation studies of products having OS/Atypical results and responsible to prepare related documents and conduct the root cause analysis.  To prepare and revise Standard operating procedures and testing methods.  Lead project of Validation of creating MDRs(Multi Data Reports) for Shimadzu HPLCs and also validation of Excel Spread sheets.  Conducted troubleshooting of QC instruments such as HPLCs.  Responsible for Calibration of HPLCs and Dissolution Apparatus and its complete reporting.  To perform Standardization of secondary standards through primary standards and also book all receiving standards into Info Lab (LIMS) along with Certificate of Analysis for proper tractability. Show less



A.D. Envirotech Australia Pty. Ltd.

• Environmental Services
• 1 - 100 Employee

• Analytical Chemist

  • Jul 2018 - Dec 2018

   Responsible for method development of Organic and Inorganic compounds in a soil and water.  Responsible for Analytical Method Validation and Proficiency Testing.  To perform commercial testing of a soil (BTEX, PAH, Metal Analysis and PFAS analysis) using various analytical techniques and instrumentation, including UV-Spectrophotometer, ICP-OES, GCMS and LCMS.  Involved in LIMS Project and develop the different methods and its parameter into LIMS and also validate the formulas for laboratory calculation.  Responsible to ensure Calibration and Preventive Maintenance of Instruments. Show less



Getz Pharma

• Pakistan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Manager Quality Control

  • Jan 2017 - Apr 2018

   To Supervise Semi Finished Goods section and make a plan to assign the tasks among team and ensure daily activities for plan conformace. Responsible to check and sign the Analytical reports and analyst’s raw data log book. Responsible to coordinate with vendors for external Calibration and Preventive Maintenance of QC Instruments. Responsible for troubleshooting of QC instruments and coordianted with service engineers to rectify problems when any malfunction of instuments reported. Responsible to perform “Transfer of Analytical Procedure” analysis for those methods that are transfered from Research & Development department. To Perform Investigation studies of products having OOS/Atypical results and responsible to prepare related documents and conduct the root cause analysis. To prepare and revise Standard operating procedures and testing methods. Responsible to creat “Product Inspection Plans” on SAP for data recording. To involve in QC budget activities and prepare purchase requisition for QC instruments and accessories. Responsible to train and develop new inductees and prepare their training records. Show less

• Assistant Manager

  • Jan 2014 - Dec 2016

   Supervised Semi Finished Goods section and make a plan to assign the tasks among team and ensure daily activities for plan conformace. Analysed commercial samples, using various analytical techniques and instrumentation, including High performance liquid chromatography (HPLC) and spectroscopy( UV Spectrophotometer) and any other standard pharmacopoeial test methodology. Responsible to ensure Calibration and Preventive Maintenance of QC Instruments. Performed “Profeciency Testing” for ISO 17025 and “Third Party Testing” Responsible to perform “Transfer of Analytical Procedure” analysis for those methods that are transfered from Research & Development department. Performed Investigation studies of products having OOS/Atypical results and responsible to prepare related documents. Involved in Risk assessment studies. Assisted in troubleshooting of QC instruments such as HPLCs. Involved in Risk assessment studies. Involved in analytical method validation for products. Responsible to maintain the inventory of chemicals and spares of QC instruments Show less

• Senior Executive Quality Control

  • Jul 2012 - Dec 2013

   Analysed R&D samples and commercial samples, using various analytical techniques and instrumentation, including Gas chromatography(GC) and high performance liquid chromatography (HPLC) and spectroscopy (infrared and ultraviolet) and any other standard pharmacopoeial test methodology. Carried out work related to analytical method development, method validation, cleaning validation studies, hold time studies and market complaints. Ensuring work complies with cGMP and regulatory requirements. Reporting all testing results and deviations encountered during analysis of products. Utilizes basic analytical knowledge and experience in carrying out assigned investigation activities such as OOS & OOT. Also involved in QA Investigation team to make investigations report for the disposition of batch. Responsible to prepare and standardize lab reagents and test solutions.  Participated in the calibration and maintenance of all lab equipments. Assisted in troubleshooting of QC instruments or procedural problems as they arise.  Responsible to maintain study documentation and laboratory records. Participated in corrective action of problems. Show less



OBS Pakistan Pvt. Ltd.

• Pakistan
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Chemist

  • Nov 2009 - Jul 2012

  • Using analytical techniques and instrumentation, such as gas and high performance liquid chromatography (HPLC) and spectroscopy (infrared and ultraviolet). • To prepare test reports, technical papers and standard specifications for the chemical product. • To perform Method Validation & Calibration of instruments used in Chemical lab. • To find out different ways to optimize the quality of an existing chemical product. • To find out different ways to optimize the quality of an existing chemical product. • Involved in Raw Material, Finished product, Stability Testing, Hormonal product testing & Water testing. • Preparing test solutions, chemical compounds and performing various laboratory tests. • Compliance, Inventory System, Electronic Data Backup, improve Lab Efficiency, Cost Saving and provide assistance to Manager QC for lab activities. Show less



Hilton Pharma Limited

• Pakistan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Chemist

  • Dec 2007 - Nov 2009

  • Trained as a IPQA inspector to ensure compliance with GMP in production area (Manufacturing Area & Packaging Area). • Reviewed batch documents for reconciliation and other GMP requirements. • Performed Raw Material, Finished product, Stability Testing, Water testing & Packaging Testing • Performed Raw Material Sampling • Registration Dossier for new products to submit in Ministry of Health. • Trained as a IPQA inspector to ensure compliance with GMP in production area (Manufacturing Area & Packaging Area). • Reviewed batch documents for reconciliation and other GMP requirements. • Performed Raw Material, Finished product, Stability Testing, Water testing & Packaging Testing • Performed Raw Material Sampling • Registration Dossier for new products to submit in Ministry of Health.