Ammad Nazar

Experience

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  Opal Laboratories Pvt Ltd

  Aug 2005 - Sept 2007

  Quality Control Analyst

  - Finished products analysis - Raw materials analysis - Packaging material analysis- Preparing and Updating SOP’s of Finished Product & Raw Material.- Preparation and standardization of volumetric and test solutions- Daily planning of Q.C activities

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  Otsuka Pakistan Ltd

  Sept 2007 - Jul 2012

  Quality Control Executive

  - Analysis of Finished product, raw material and water treatment plant.- Analysis of samples on HPLC, amino acid analyzer and atomic absorption spectrometer.- Calibration of laboratory instruments.- Validation of analytical methods.- Ensure conformance of cGMP, GLP in manufacturing and in laboratory.- Conducted a self assessment audit to evaluate compliance with ISO 17025:2005- Prepare budgetary proposals and perform assessment for acquiring laboratory equipment and supplies- Preparing and reviewing of SOP’s for raw material, products and instrument handling Show less

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  Hilton Pharma Limited

  Jun 2012 - Feb 2025

  • Working as Deputy Manager Quality Operations in Hilton Pharmaceuticals Private LimitedSince 1st April 2015 and additionally as QA Manager since August 2017 to 2019. Responsibilities include but are not limited to:- Manage and ensure all activities of QA department including validation, failure investigation, Change management system, deviation management system, CAPA, Annual product review, internal audits, vendor/supplier qualification, complain management and training.- Manage activities for new projects including facility, utilities and equipment qualification. - Manage Quality Performance Review meetings and brief plant management on current quality status, activities and their progress on monthly basis.- Assist Director QO and Director NPD in core quality related issues.- Team member for organizing external audits of regulatory bodies, certification bodies as well as audits of exporting countries.- Prepare and manage execution of the Validation Master Plan, qualification of critical equipment (DHS and autoclave) and facility, media fills, process validation etc. Show less - Manage and ensure all activities of QA department including failure investigation, Change Management System, Deviation Management System, CAPA, Annual product quality review, internal audits, and vendor/supplier audits, complaint management, IPC team, Gemba walk, Data Integrity, External audits and technical & regulatory compliance training.- Ensure compliance of contractual manufacturing as per cGMP, quality agreement and regulatory requirements through follow-up audits, deviation and its CAPA, market complains. Show less - Manage all the validation activities of company.- Prepare and manage execution of the Validation Master Plan- Manage facility qualification for new projects as well as existing area.- Conduct validation review meetings and brief plant management on current validation activities and their progress.- Member of the review board for SOP’s and other official documents for Quality Assurance department.- Prepare standard operating procedures (SOPs) for validation section.- Act as an active team member in conducting Internal Audits.- Manage prospective, concurrent and retrospective validation of OSD, liquid manufacturing, injectable and dry powder products.- Development Protocol for prospective validation, concurrent validation and retrospective validation and finally generate the Validation Report.- Manage qualification of critical equipment such as Dry Heat Sterilizer and Steam Sterilizer.- Manage Aseptic Process Simulation runs for Injectable and Biotechnology Area.- Conduct technical and regulatory compliance training sessions for officers, supervisors and team leads.- Annual product quality review reports.- Assist QAM in core quality assurance department activity on as need basis.- Plant team member for organizing external audits of regulatory bodies, certification bodies as well as audits of exporting countries.Achievements - Biotechnology Area Project:Facility, equipment, and systems (HVAC, Water and Compressed) qualification.- Oral Solid Dosage Packing Area Project:Facility, equipment, and HVAC system qualification.- Injectable Area and HVAC re-qualification:- Barcoding System:Validation of barcoding system for material dispensing verification.- Training & Presentation:Delivered presentation on GMP, APQR, Aseptic Manufacturing Practices, 5S, Cost of Quality, QC tools etc.- Knapp-Kushner Test:Knapp-Kushner test for Ampoule inspection Machine. Show less Process ValidationProduct Retrospective ValidationManufacturing Equipment Qualification & ValidationAnalytical Instrument QualificationRevalidation of Steam sterilizer (Autoclave)Aspetic Process Stimulation (Media Fill)Area Qualification of Oral Solid Dosage, Oral Liquid Dosage, Injectable area, Cephalosporin area and Biotechnology Plant.Actively involved in different studies including yield of production processes, dispensing of material in different production areas especially in injectable area.Annual Product Quality Reveiw. Show less

  • Manager Quality Operations (Site Quality Lead)

    Nov 2022 - Feb 2025

  • Deputy Manager

    Apr 2015 - Nov 2022

  • Quality Assurance Manager (Interim)

    Apr 2017 - Apr 2019

  • Assistant Manager Validation

    Apr 2014 - Mar 2015

  • Senior Officer Validation

    Jun 2012 - Mar 2014
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  Hoechst Pakistan Limited

  Jan 2025 - now

  Head of Quality Assurance