Iftikhar A Jafri

****-******* *** ***

MD-*****

240-***-****

Summary

Technical and results oriented professional with extensive senior leadership experience in the pharmaceutical industry. Subject matter expert in process, cleaning, equipment/ systems including facility/utilities and process scale up. Proven ability to develop and motivate efficient teams that take pride in delivering organizational goals.

Well enhanced organizational and project management skills to achieve targeted results. Recognized as an effective team leader and maintain consistent quality commitment and customer satisfaction.

Development of Validation Master Plan (VMP) scope, which includes: Systems, equipment, methods, facilities specially during the product/ process/technical transfer from one manufacturing site to other during merger/ site closure or new or existing manufacturing sites Operations.

Technology transfer specially in the areas of Pharmaceutical products manufacturing, packaging and Testing from one site to another specially during Site Closure/Merger/transfer of products e.g. (Solid/Liquids/ Parenteral/

Hands on experience in the implementation of: Quality Management System, Regulatory Compliance for the Quality Audit/Inspection of Drug Substances and Drug Product facility & CAPA Commitments (FDA, European Agency & other Regulatory Agencies) Lead Auditor for the approval of Drug Substances Manufacturers, Supplier for Medical Devices Change Management & Deviation.

Demonstrated and build reputation as an energetic, motivated, creative self-starter with strong leadership skills and ability to develop, and lead technical teams focused on achieving corporate objectives and goals. Possess excellent technical, investigative, and interpersonal skills.

Technical Skills

Hands on experience on Current Good Manufacturing Practices (cGMP) specially when participating in Technology Transfer for pharmaceutical process, validation activities which includes: Process Design (PD), Process Qualification (PQ), Operational Qualification (OQ) and Continued Process Verification (CPV).

Development of Validation Master Plan (VMP) which outlines the principles refer to the qualification of facility, respective system, equipment, methods (Testing and Manufacturing) and areas which need validation guideline/timeline to achieve and maintain a qualified facility to ensure Process Control Strategy.

Lead GMP Auditor for qualifying new or existing source or supplier of Drug Substances, Excipient, Primary Containers and Closures.

Verify that CAPA System Procedure(s) that address the requirements of Quality System regulation have been defined and Documented

QMS Implementation for the Drug & Devices combo Product (21 CFR Part 820).

Experience of manufacturing, testing, dispensing of controlled substances and their necessary control for their storage/consumption as per the regulations/Compliance of Drug Enforcement Administration (DEA).

e.g. Alprazolam, Phenytoin, Benzodiazepines, Morphine, Diazepam etc.

Post Market Surveillance & Pharmacovigilance of Marketed Products.

Site closure/ Plant & product rationalization/transfer and regulatory filing and Approval. (Global Merger/ Take over/ buyout). Transfer of the products as a result of Global Mergers or Acquisition.

Vaccine Development and typical Roadmap steps: (Exploratory/Preclinical/Clinical/Reg.Review and Approval etc.)

Investigational New Drug (IND) application filing by developing Typical Product Profile (TPP) of selected product for FDA submission.

Critical review of EBR (Executed Batch Records) for Drug Substance/Product and its approval and identify Quality Issues and suggest Quality Improvement. Review of GMP Documents

Project & QA management /organization, Vendors (Drug Substances/Excipient) Qualification and approvals

Skills: Effective Communication (Verbal & Written), Efficient Time Management, Problem-Solving and Agile Mindset.

Education & Certifications

University of Sheffield -UK

BS. With Major: Chemistry, Electives: Microbiology and Physiology

MS. Organic Chemistry by Research (Sigma tropic Anionic Reaction)

PhD Degree in Organic Chemistry

Certificates

Certified Quality Lead Auditors

Pfizer Corporate Quality Auditor- USA

Certified Green Belt/Six Sigma

Pfizer’s Master Black Belt

Professional Experience

Novavax. Inc. Gaithersburg, MD 20878 Dec 2020 – till to-date

GMP Lead Quality Assurance Specialist/ Auditor

Summary of Key Responsibilities:

Auditor GMP Lead Quality Assurance Manager Novavax. Inc.

Gaithersburg, MD - December 2020 - November 2022

Timely release of all products (Drug Substance/Drug Products) by reviewing EBRs submitted by all CMO. Review of the executed batch records of finished goods to verify conformance with product specifications and meeting the regulatory requirements.

All the deviation and Change Control reported in during manufacturing, of Drug Substance and Drug Product need critical review before release the final products.

Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.

Ensure if CAPA reported then all the 4 stages of CAPA i.e. Identification, Evaluation, Investigation and Analysis were documented. followed by reported: Action Plan which will include Implementation plan and Follow up.

Provided regular updates to leadership team on quality metrics by communicating consistency problems or production deficiencies for all the Executed Vaccine Batches at different CMOs. Conducted investigations into questionable test results.

Participated in the lab scale process validation for the vaccine products which also include development of equipment qualification/validation protocol, defining the acceptance criteria for the data generated.

Pneuma Respiratory, Inc., Boone-NC-USA Dec 2019 – Sep 2020

Director Quality Operations & Lead GMP Quality Auditor

Summary of Key Responsibilities:

Lead of Quality, Medical Device, will hold the key competence within quality oversight of medical devices and combination products. The Director of Quality will be responsible for the quality assurance of all device activities in development of new device projects and the commercial manufacturing of devices.

CCOQ (Components Compatibility Operation Qualification) for the plastic drug containers integral part of the devices. Also perform the CCIT (Container Closure Integrity test) to confirm the plastic containers has no impact on the stability of drugs in aqueous/solvent media without leaching effect.

Lead of Quality to oversee the quality department and the company’s QMS for driving a culture of quality throughout the company. Development of Validation Master Plan for Devices and Primary components.

Ethylene Oxide (EO) Sterilization of Cartridges Assembly after Sterile Barrier packaging and then subject to EO Sterilization Chamber. which was qualified as per the design. The entire sterilization cycle was audited virtually by the company. The final Validation documents was reviewed by the Quality Team of Pneuma Respiratory Inc. here in Boone (NC), USA.

Investigational New Drug (IND) application filing by developing Typical Product Profile (TPP) of selected product & Devices for FDA submission. (Drug and Device Combination Product)

An Example of CAPA in manufacturing is when there is defective product, this is responsibility of person working in the area to ensure a CAPA Summary which will identify a discrepancy or problem during the manufacturing or testing of the product,root cause of the identified problem, Identify the corrective action taken to prevent recurrence.

U.S. Pharmacopeia NF May 2017 – Oct 2019

Sr. Consultant-Quality Operations. Pharmacopoeia

Rockwell, MD-20852-1790 - May 2017 - October 2019

Lead Quality Auditor for Government Drugs Testing Laboratory of Asian/African Countries.

Responsible for the development, implementation, and training of Quality Management System (QMS) to the colleagues of Government Drug Testing Laboratories of Asian and African Countries.

Conducted routine QC Laboratory inspections, identifying areas needing improvement, eliminating safety hazards posed to analysts or environment. Ensure continued compliance with respective regulations and readiness for the inspection of regulatory authorities.

Responsible for Post Market Surveillance training to Quality Assurance colleagues in order to ensure all the marketed products are meeting the Safety and Efficacy requirements.

Prepare and submit the CAPA and make responses related to regulatory (FDA & EU) observations, e.g., submission of implementation plan for GMP Gaps and deficiencies identified during audits.

Pfizer Inc. Ltd

Sr. Manager Quality Operations & Compliance Pfizer Inc.

New York City, NY - October 1995 - April 2017

Note: While working for Pfizer Inc. from 1995-2017, had an opportunity to participate 3 Global mergers of Pfizer Inc. with Warner Lambert, Pharmacia Upjohn and Wyeth (American Home Products). This was great learning opportunity in the areas of Regulatory filling for merger approval, product transfer, Labeling/Packaging Change, Product Transfer, Plant Consolidation, Plant Closures/Product Shifting/Product Rationalization. Regulatory interactions of US/Europe and Regulatory authorities of some Asian Countries. Important things during all these mergers, the merged new company’s name remain Pfizer Inc.

1. Pfizer Inc. Site Quality Lead & Regulatory Compliance- (Oct.1995-Dec.2000)

Followed quality standards and procedures to minimize errors and maximize customer satisfaction.

Qualification of new Chemical/Microbiological testing laboratory right from the beginning of development of laboratory structure from the layout/grey Structure/HVAC system/Dust control/EHS compliance as per Pfizer Guideline. Qualification of Microbiological laboratory/Clean Room/ Autoclave and Biological cabinet Qualification under Simulated Conditions.

Qualification of Autoclave/Sterilizers/Water System and Incubators. Clean Room qualification dedicated for sterility testing.

Ensure that all quality issues and defects are appropriately identified, investigated and resolved as per quality/ GMP guideline.

Lead team meeting with QA, Manufacturing, Supply Chain to ensure timely availability/approval/ of all products as per plan. Detail of CAPA if reported and what is the status

Work Closely with Company Regulatory Department for the submission of Regulatory filing or sending response to regulatory authorities.

Act as Lead Auditor to participate in Quality Audit/Inspection and Approval of APIs/ Excipient and contract manufacturing sites for drug product. (Sterile Products both liquid and Powders). Ensure each CAPA has been investigated and corrective action has been appropriately taken.

2.Pfizer & Warner Lambert- Head of Quality Operations (Dec.2000-Dec.2005)-Merged Company is Pfizer Inc.

Assigned responsibility of QO for both Pfizer and Warner Lambert.

Assigned the responsibility of consolidation of Manufacturing and Quality Operations of Warner Lambert with focus on Solid Dosage Form.

Responsible for the total quality operations of Asian Plants (Where both Pfizer and Warner Lambert plants were available.). Site Closure/Product transfer/ Validation (Mfg. Process and analytical methods) of assigned products as per the change control detail.

Technical Review of currently renovated Sterile manufacturing/Filling of liquid/powder injection including all the sterilizer/WFI system/Clean steam generator and Dry/Moist Heat Sterilizer. As a result of critical/technical review, this was recommended that the Sterile Area currently making aseptically filled/Terminally Sterilized products are far from the basic/minimum requirement for producing Liquid Injection as per the Pfizer Standards. Therefore, decided to stop producing Liquid/Powder injection.

As a Head of QO, responsible for the merger of QO activities and consolidating and aligned the entire activities for the merged company (Pfizer and Warner Lambert) and implement a uniform Procedures and Policies of Pfizer. Listed if any open CAPA and reason for the same and the next step.

Gap analysis of all testing procedure and list down all the products which need to transfer under the name of Pfizer for Regulatory Approval. (Change of Labeling as per Regulatory Requirements.)

3. Pfizer-Pharmacia-Senior Manager of Quality Operations (Dec.2005-2010) Merged Co. Pfizer Inc.

Overall Quality Operations of both Pfizer and Pharmacia.

Responsible of merger of two operations including transfer of Pharmacia products to Pfizer Plant. (Closure of Pharmacia Plant). Key stages of the Technology Transfer process of injectable and Oral Solid Dosage form.

Transfer of the locally manufactured Oral Solid dosage form products and transfer the product to Pfizer plant as per the local regulation’s guideline.

Review of VMP and necessary changes/revision and inclusion of equipment/ products/ facility and systems: HVACs, Water (Purified/WFI) and Sterilizers.

Identify and qualify a suitable contract manufacturer as per Pfizer guideline for the transfer of liquid injection (Aseptically fill).

Inspect oral dosage form products manufacturing for compliance with established Pfizer policies and procedures.

Key Stages of the Technology Transfer (Tech Transfer) process of Injectable and oral solid dosage form include Validation, Stability data collection, data review, regulatory filling for approval.

4.Pfizer-Wyeth- Quality Operations-Director (December 2010-2017)-Merged Company-Pfizer

Pfizer agreed to purchase/acquire Wyeth main reason for this merger was Prevenar, a vaccine for infants against pneumococcal disease. Enbrel, an Arthritis drug.

Supplier Qualification activities, inspection/approval of new suppliers for Drug Substances, Drug Products. Detail of CAPA is required with the action plan

Bioequivalence of fixed-dose Combination Anti TB products i.e. Myrin- P Forte That Contains Rifampicin, Isoniazid, Ethambutol and Pyrazinamide. Conducted at Pfizer Investigational Site, Singapore.

Worked Closely WHO Geneva Preparation and submission of dossier, Selection/Recommendation of Comparator Drugs by WHO required for the study. Preparation of Manufacturing Site for Anti-TB Products as per the recommended Design by WHO for their Certification/Approval.

Preparation of Quality Agreement between Pfizer and Contract giver for Pfizer’s Products.

Ensured effective communication to colleagues and ensure implementation of corporate policies & procedures

Warner Lambert, NJ

1.Sr. Manager Quality Assurance and Validation-June 1986-Dec. 1989

2. Associate Quality Operations-Director January 1990-Sep.1995

Developed in drafting, negotiating, and maintaining quality agreements with different suppliers of an API and Excipients.

Supplier Qualification of All APIs and Excipients as Lead Supplier Auditor of Warner Lambert. Detail of Change Control, Deviation and CAPA with the detail action plan.

Develops timelines for customer/market complaint investigation to ensure that reporting is performed on time and complaints are addressed in a timely manner and Provide training on complaint handling for new employees and cross functional teams

Works independently to investigate complaints in compliance with company procedures and suggest corrective action or reply to complainant on timely manner. Participated in global Quality initiatives ensuring the implementation of Uniform Quality Policy, input is provided for the implementation activities.

Quality reviews and approved Validation Master Plan including Manufacturing Process Validation Qualification, Analytical Method Validation, Equipment Qualification (Analytical and Manufacturing), Validation of Purified water system/WFI/ HVAC system etc.

Glaxo Smith Kline (GSK) Apr 1982 – May 1986

Quality Assurance Manager

Organized and participated in Suppliers/ Vendors audits Raw and Finished Materials.

Developed and maintained control documents to facilitate Quality Systems Reviewed & approved executed protocols, Change control, CAPA’s and deviations.

Responsible to perform complaint management and reporting activities that include device assessments and submissions, complaint coding, dispositions, etc. Development of standardized complaint analysis frameworks that can be leveraged across businesses and functions

Developed and implemented cGMP, good laboratory practices (GLP) and validation programs to consistently meet regulatory and industry standards. Performed gap analysis & provide guidance to improve HVAC, WFI & Clean Steam Systems

Ensured facility/ Utilities, processes, cleaning, methods, and computerized systems are maintained in a validated state to consistently meeting regulatory requirements.

Updated Tuesday Oct.24, 2023

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