Muhammad Ajmal Karim Khan

Experience

• 

  Parke-Davis Pakistan (US Based Multinational Company).

  Aug 1999 - May 2000

  Production Officer

  Supervision of work in Tablets and Capsules Areas

• 

  Wyeth Pakistan Limited (US Based Multinational Company).

  Jun 2000 - Nov 2006

  QC Officer

  • Performing testing of various samples of Raw Materials, Bulks and Finished Products using Conventional Methods and different sophisticated techniques along with latest instruments e.g.: HPLC, Atomic Absorption, FT-IR, UV Spectrophotometer, Dissolution Apparatus, Karl Fischer Apparatus, Refractometer , Polarimeter, Viscometer, pH Meter, Manometer etc.• Well-versed in Stability Studies Testing.• Involved in Analytical, Process and Cleaning Validations.

• 

  Alfred H Knight

  Nov 2006 - Nov 2007

  Lab In charge

  • Establish Third Party Lab for Mineral Testing.• Run Third Party Lab for Mineral Testing.• One month on job training at Alfred H Knight Lab laboratory, Turkey.

• 

  Pfizer

  Nov 2007 - Aug 2017

  • Ensure compliance with Local/Government Regulations in relation to Quality and Safety.• Responsible for implementation of ISO-9001: 2000 elements in daily GMP practices during process/operations.• Responsible for Internal and External Supplier's Audit as a Lead Auditor. I did Over 200 Audits of Suppliers and Distribution centers.• Provide Training on “Pfizer Human Performance” (Human Error Reduction) to all colleagues facilitate for preparation of Proactive Projects to reduce Human Error. • Actively participated in ISO surveillance Audit.• Support Third parties on Quality issues,• Support Third parties on preparation of Corporate Audit CAPA and their implementation.• Involved in preparation of Quality Agreements.• Correspondence of market complaints with contract manufacturer.• Conduct and Prepare reports for Internal & External Audits as a Lead Auditor on behalf of MSQA Pfizer International Audit department.• Monitoring and audit the vendor to ensure quality & implementing necessary improvements.• Developed Raw , Packaging Materials Suppliers and Distributors as per cGMP and International Standards. • Follow up of Internal Audit observations completion and External / International and MOH Audits observations completion certification from concerned departments.• Assist in root cause investigation for Non-conformities and customer complaints and thereby develop an adequate procedure to prevent recurrence.• Worked as Mock Recall Coordinator.• Handling and investigation of Customer Complaints and ensure timely completion of Complaint in PCOM.• Worked as a PHP facilitator and Trainer of Pfizer Pakistan’s both site.• Involve and facilitate cross functional team to find out true root cause by using Method 1 and PHP tools in Investigations.• Worked as a OE coordinator. Identify, develop and finalize Operational Excellence (OE) Projects Show less I have over fifteen years of experience in the American Based Multinational Pharmaceutical Companies. I have worked with equal competency in Quality Control and Production Area. I have also established third party mineral testing laboratory for UK Based Multinational Company “ALFRED H KNIGHT”. • Responsible for implementation of ISO-9001: 2008 elements in daily GMP practices during process/operations. • Conduct Suppliers and Distributors Audits • Provide Training on “Pfizer Human Performance” (Human Error Reduction) to all colleagues facilitate for preparation of Proactive Projects.• Actively participated in ISO surveillance Audit.• Ensure implementation of corporate requirement in plant. • Working as an Internal and External supplier Lead Auditor.• Support Third parties on Quality issues,• Support Third parties on preparation of Corporate Audit CAPA and their implementation.• Prepare Internal Audit Schedule.• Conduct and Prepare reports for Internal & External Audits on behalf of MSQA Pfizer International Audit department.• Follow up of Internal Audit observations completion and External / International and MOH Audits observations completion certification from concerned departments.• Assist in root cause investigation for Non-conformities and customer complaints and thereby develop an adequate procedure to prevent recurrence.• Worked as Mock Recall Coordinator.• Data Collection and data entry of BSC (Balance Score Card) for controlling PGM (Pfizer Global Manufacturing) metrics.• Controlling the Quality Control soft ware LIMS (Laboratory Information Management System)• Handling and investigation of Customer Complaints and ensure timely completion of Complaint in PCOM.• Involve and facilitate to find out True root cause by using Method 1 and PHP tools in Investigations.• Preparing, reviewing and updating of Sops, Products/ raw materials monograph and testing Methods. Show less I have over seventeen years of experience in the American Based Multinational Pharmaceutical Companies. I have worked with equal competency in Quality Control and Production Area. I have also established third party mineral testing laboratory for UK Based Multinational Company “ALFRED H KNIGHT”. Currently I am working as a Junior Manager Quality Assurance in Pfizer Pakistan Limited (legacy Wyeth). I am ISO 9001: 2008 IRCA certified Lead Auditor from DNV- GL. I am responsible for Internal and External Supplier's Audit as a Lead Auditor. I did Over 200 Audits of Suppliers and Distribution centers. I am also Pfizer Human Performance (Human Error Reduction) qualified facilitator and trainer. Show less

  • Jr. Manager QA / IRCA Certified ISO 9001:2015 Lead Auditor/Human Error Reduction Trainer

    Apr 2012 - Aug 2017

  • Junior Quality Assurance Manager

    Nov 2007 - Aug 2017

  • Jr. Manager QA

    Nov 2007 - Aug 2017
• 

  ICI Pakistan Limited

  Aug 2017 - now

  Brief Summary : I have over twenty years of experience in the American Based Multinational Pharmaceutical Companies. I have worked with equal competency in Quality Control and Production Area. I have also established third party mineral testing laboratory for UK Based Multinational Company “ALFRED H KNIGHT”. Currently I am working as a Manager Quality Assurance in ICI Pakistan Limited .I am leading Quality Assurance Department and In process team.I am also responsible for Quality Oversights of all ICI ‘s Contract Manufacturers. I am ISO 9001: 2008 IRCA certified Lead Auditor from DNV- GL. I am responsible for Internal and External Supplier's Audit as a Lead Auditor. I did Over 200 Audits of Suppliers and Distribution centers. I am also Human Performance (Human Error Reduction) qualified facilitator and trainer. Key Achievements :• Successfully achieving drug license renewal from DRAP. (License transfer from Wyeth Pakistan to ICI Pakistan Limited)• Successfully represent Plant in Pfizer’s Global Quality Audit without any major/critical non-conformance.• Prepare dossiers all Wyeth and Pfizer’s Products acquired by ICI Pakistan for transfer registration from Wyeth & Pfizer to ICI Pakistan.• successfully received registration transfer letter from MOH Pakistan Show less • Ensure compliance with Local/Government Regulations in relation to Quality and Safety.• Ensure compliance of proper Gowning, Housekeeping and Hygienic Practices in GMP areas.• Preparation, Review and Control Master Batch Records and issuance of Production Batch Records.• Lead Quality Assurance In-process team.• Responsible for batch Audit and Batch Releases in SAP.• Worked as a Site Training Coordinator.• Develop Training Need Analysis of Plant Staff.• Arrange Training activities for GMP, SOP and other training as per requirements.• Prepare Plant Master Training Program.• Focus on training effectiveness by assessing Colleagues through Gemba Walk.• Responsible for reviewing the presentation & assessment of GMP trainings as per Yearly plan.• Manage the training activities of company’s staff by coordinating with area Heads, to ensure Colleagues awareness on relevant SOPs of “on the job”.• Responsible for implementation of ISO-9001: 2008 elements in daily GMP practices during process/operations.• Responsible for Internal and External Supplier's Audit as a Lead Auditor.• Handling and investigation of Customer Complaints of ICI Pakistan (HB Site), ICI Pakistan (Nutra Plant) and Cirin Pharmaceuticals Private Limited.• Working as an Internal and External Suppliers Lead Auditor.• • Monitoring and audit the vendor to ensure quality & implementing necessary improvements.• Follow up of Internal Audit observations completion and External / International and MOH Audits observations completion certification from concerned departments.• Support Third parties on Quality issues.• Responsible for Quality Oversights of all ICI ‘s Contract Manufacturers.• Support Third Parties on Quality issues.• Involved in preparation of Quality Agreements.• Worked as Mock Recall Coordinator.• Worked as a OE coordinator. Identify, develop and finalize Operational Excellence (OE) Projects. Show less

  • Manager Quality Assurance

    Aug 2018 - now

  • Jr. Manager Quality Assurance

    Aug 2017 - Jul 2018