Grzegorz Makowski

Grzegorz Makowski Email and Phone Number

Head of Stability Department at Polfa Tarchomin S.A. @
Grzegorz Makowski's Location
Warsaw, Mazowieckie, Poland, Poland
Grzegorz Makowski's Contact Details

Grzegorz Makowski work email

Grzegorz Makowski personal email

n/a
About Grzegorz Makowski

- Planning stability studies during drug product development; from CMC (chemistry, manufacturing, and control) through clinical trial phases I and II until phase III, drug product registration and post-registration control - Planning and managing drug products and active substances stability studies for global registration- Implementing LIMS (Laboratory Information Management System); as the Project Manager, Consultant and Advisor - Implementing Accelerated Stability Studies for various drug product forms and APIs- Leadership experience, both people and projects- Pharmaceutical industry big experience – solid dosage forms, parenteral drugs, ophthalmic drugs, lyophilized drugs- Conducting trainings concerning stability testing; lecturer and chairman at conferences, workshops and seminars- Initiating and coordinating stability studies for all climatic zones according to ICH, WHO, ASEAN, SADC, GCC and national requirements and for any specific stability tests - Managing projects during pharmaceutical drugs development- Preparing documentation for pharmaceutical drugs global registration - Pharmaceutical drugs development knowledge- Preparing and providing stability reports regarding drug products registration and clinical studies in EU and non EU countries- Consulting and training for international companies in case of stability studies for various types of drug products and active substances- Consulting and training for Polish pharmaceutical companies

Grzegorz Makowski's Current Company Details
TZF Polfa

Tzf Polfa

Head of Stability Department at Polfa Tarchomin S.A.
Grzegorz Makowski Work Experience Details
  • Tzf Polfa
    Head Of Stability Department At Polfa Tarchomin S.A.
    Tzf Polfa Jul 2020 - Present
    Warsaw, Mazowieckie, Poland
    - Managing stability studies programs for APIs and drug products various formulations during development, registration and post registration phases - Managing Annual Products Quality Reviews realization
  • Polfa Tarchomin S.A.
    Manager Of Quality Documentation & Stability Testing Department At Polfa Tarchomin S.A.
    Polfa Tarchomin S.A. Sep 2018 - Jun 2020
    Warsaw, Masovian District, Poland
    - Managing Quality System documentation: analytical methods, methods validation, Quality Specifications, Quality Control documentation- Managing stability studies programs for APIs and drug products various formulations during development, registration and post registration phases
    View
  • Self-Employed
    Stability Testing Consultant
    Self-Employed May 2018 - Aug 2018
    View
  • Aptuit
    Stability Research Leader
    Aptuit Nov 2017 - May 2018
    Italy
    # Preparing stability studies programs for APIs and drug products for the comprehensive development: preclinical, clinical I, II and III phases and the final drug product registration # Implementing Accelerated Stability Studies design for the prototypes assessment, packaging choosing, drug development speed-up # Preparing cost efficient stability studies strategies for IMPD/ IND as well as MAA/ NDA# Cooperating with Preformulation, Formulation and Analytical Teams in order to reach the best performance in various drug product forms development i.e. tablets, capsules, suspensions (including nano-suspensions), drug powders for inhalation and other# Ensuring the GMP and GLP compliance during the drug product development
    View
  • Polpharma
    Stability Expert
    Polpharma Aug 2013 - Oct 2017
    Poland
    - Consulting for Stability Departments in Polpharma Group, both QC and R&D- Defining, managing and providing oversight of the R&D stability programs, in line with regulatory expectation, to support the setting of shelf-lives / re-test dates and to support the release specifications- Writing, review and approval of stability protocols and reports- Monitoring stability studies in Polpharma Group; results, documentation, registration dossiers- Training concerning stability studies for various types of drugs and forms for Polpharma Group sites, other pharmaceutical companies- Preparing and providing stability reports regarding drug products registration and clinical studies in EU and non EU countries- Investigating of OOT/OOS results generated during a study and resolution of issues according to appropriate quality procedures- Attend and input in cross functional project teams established to ensure effective development of portfolio products where required- Comply with and to provide input into company quality systems- Supporting the development and maintenance of company quality systems to ensure continued compliance with GMP- Preparing and providing drug products shelf life and storage conditions declarations - Selecting right prototypes, formulations, packaging and potential markets based on knowledge from ASAP (Accelerated Stability Assessment Program) and feasibility studies
    View
  • Polpharma
    Stability Team Manager
    Polpharma Jun 2011 - Aug 2013
    - Consulting for Stability Departments in Polpharma Group- Overall responsibility for the coordination of stability studies conducted by the R&D Department in accordance with regulatory expectations- Defining, managing and providing oversight of the R&D stability programs, in line with regulatory expectation, to support the setting of shelf-lives / re-test dates and to support the release specifications- Writing, review and approval of stability protocols and reports- Investigating of OOT/OOS results generated during a study and resolution of issues according to appropriate quality procedures- Comply with and to provide input into company quality systems- Leading the Team of a dozen analysts- Supporting the development and maintenance of company quality systems to ensure continued compliance with GMP- Managing chemical, physical and microbiological stability studies for more than 200 products- Preparing and providing stability reports regarding drug products registration and clinical studies in EU and non EU countries- Preparing and providing drug products shelf life and storage conditions declarations - Participating in and working with the Project Teams during drug products development- Collecting reports from: Formulators, Drug Development Teams, Validation Team, QC Department- Report to: R&D Director, QA Director, Regulatory Department; Board of Directors
    View
  • Polpharma
    Stability Team Leader
    Polpharma Sep 2010 - May 2011
    - Leading the Team of a dozen analysts- Managing chemical, physical and microbiological stability studies for about 200 products- Preparing and providing stability reports regarding drug products registration and clinical studies in EU and non EU countries- Preparing and providing drug products shelf life and storage conditions declarations - Participating in and working with the Project Teams during drug products development
    View
  • Polpharma
    Stability Data Coordinator
    Polpharma Feb 2008 - Aug 2010
    View
  • Polpharma
    Stability Team Coordinator
    Polpharma Apr 2007 - Jan 2008
    View
  • Polpharma
    Stability Senior Specialist
    Polpharma Mar 2005 - Apr 2007
    View
  • Polpharma
    Stability Administrator
    Polpharma May 2004 - Mar 2005
    View

Grzegorz Makowski Skills

Gmp Pharmaceutical Industry Pharmaceutics Regulatory Requirements Change Control Stability Studies Gxp Regulatory Submissions Microbiology Capa Sop Regulatory Affairs 21 Cfr Part 11 Fda Trend Analysis R&d Validation Lims Glp Computer System Validation Product Development Hplc Pharmacovigilance Quality Auditing Quality System Quality Assurance Clinical Research Generic Programming Chemistry Clinical Trials Chromatography Clinical Development Cleaning Validation Cro Drug Development Ich Gcp Medical Devices Quality Control Research And Development Standard Operating Procedure Ectd Medical Writing Vaccines Process Simulation Gcp

Grzegorz Makowski Education Details

Frequently Asked Questions about Grzegorz Makowski

What company does Grzegorz Makowski work for?

Grzegorz Makowski works for Tzf Polfa

What is Grzegorz Makowski's role at the current company?

Grzegorz Makowski's current role is Head of Stability Department at Polfa Tarchomin S.A..

What is Grzegorz Makowski's email address?

Grzegorz Makowski's email address is niezalezny@wp.eu

What schools did Grzegorz Makowski attend?

Grzegorz Makowski attended Uniwersytet Technologiczno-Przyrodniczy Im. Jana I Jędrzeja Śniadeckich W Bydgoszczy.

What are some of Grzegorz Makowski's interests?

Grzegorz Makowski has interest in Sailing (Certified Yachtmaster), Triathlon.

What skills is Grzegorz Makowski known for?

Grzegorz Makowski has skills like Gmp, Pharmaceutical Industry, Pharmaceutics, Regulatory Requirements, Change Control, Stability Studies, Gxp, Regulatory Submissions, Microbiology, Capa, Sop, Regulatory Affairs.

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