Dr Michael Crothers

Dr Michael Crothers Email and Phone Number

Chief Quality and Scientific Officer at Phebra Pty Ltd @ Phebra Pty Ltd
Dr Michael Crothers's Location
Sydney, New South Wales, Australia, Australia
Dr Michael Crothers's Contact Details

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About Dr Michael Crothers

I possess a comprehensive understanding of the international GMP regulatory requirements surrounding pharmaceutical quality assurance and product development and have extensive experience in meeting these requirements during my career. My experience includes the development, manufacturing, quality control and the authorised release of sterile and non-sterile pharmaceutical products. I have a long track record of successfully executing tactical operating plans and I have a long history of delivering complex projects within demanding deadlines and budgets. The development projects I lead always meet international regulatory standards. I have an extensive academic career; I possess an Honours Degree in Chemistry and a Masters of Research in Molecular Engineering. My PhD in Pharmacy was funded by GlaxoSmithKline and I completed my research and received my doctorate in 2002 from Manchester University. I have been involved in several projects and my work has been published on a number of occasions. I am a strong communicator with exemplary interpersonal skills which allows me to build effective, long lasting relationships with clients, colleagues and external stakeholders. In my field, there is extensive liaison with regulatory bodies and external stakeholders and thus one must be able to communicate effectively and build a rapport with these individuals and attempt to foster an open dialogue to improve the environment the company is operating within. I have worked in a myriad of different countries and companies which has given me a key insight into the culture of different companies and organisations. This allows me to effectively lead a team of talented individuals from a range of different backgrounds and I can ensure everyone within my team operates at their maximum capability by ensuring that each individual knows how important their role is to the projects overall success.

Dr Michael Crothers's Current Company Details
Phebra Pty Ltd

Phebra Pty Ltd

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Chief Quality and Scientific Officer at Phebra Pty Ltd
Dr Michael Crothers Work Experience Details
  • Phebra Pty Ltd
    Chief Quality And Scientific Officer
    Phebra Pty Ltd Mar 2021 - Present
    Sydney, New South Wales, Australia
    I am currently the Chief Quality and Scientific Officer for a pharmaceutical manufacturing facility in Sydney that manufactures mainly sterile medicines and supplies over 60 products for critical therapeutic needs. I am responsible for all company QA, QC and validation activities. I am also responsible for new product development and introduction and currently manage a combined team of over 30 talented individuals.
  • Phebra Pty Ltd
    Quality Manager
    Phebra Pty Ltd Dec 2016 - Mar 2021
    Sydney, Australia
  • Jurox Pty Ltd
    Global Head Of Quality
    Jurox Pty Ltd Mar 2015 - Dec 2016
    Rutherford, New South Wales, Australia
    As the Global Head of Quality I reported directly to the Managing Director and I was responsible for the management of 6 QA staff, 8 QC staff and 3 validation staff members. I was a member of the Senior Management Leadership Team and I advised on all aspects of international GMP and Quality Compliance to all levels in the company, globally and including third party stakeholders. I was charged with managing the lead up preparations and I hosted inspections by the FDA, TGA and APVMA regulatory authorities. I formulated, developed and implemented a robust CAPA plan to address deficiency findings to ensure continued facility GMP compliance and approval. In addition, I was accountable for the quality assurance of all products manufactured by Jurox on a global scale. This included overall responsibility for deviation management, change management, non-conformance management, complaint handling, release for supply and CAPA systems. Implemented quality risk management principles and effective root cause analysis to problem solving. Furthermore, I implemented a quality continuous improvement programme across all relevant departments including Production, Engineering, Quality and Research and Development.
  • Custom Pharmaceuticals Ltd
    Head Of Quality Control
    Custom Pharmaceuticals Ltd Nov 2011 - Apr 2014
    Brighton, United Kingdom
    I was the most senior on-site Analyst and as such I was responsible for all Quality Control activities across 2 sites including the testing and approval of Active Pharmaceutical Ingredients, raw materials, packing materials and intermediate, bulk and finished products. As a member of the Quality Management Team, I advised Senior Management on matters relating to the operational and quality aspects of QC testing across sites. I gained extensive experience in the development, manufacture and testing of a range of solid, semi-solid and liquid dosage forms for both EU and non-EU markets. Furthermore, this role provided me with an in-depth knowledge of testing and control of drug products both during the development stage and routine commercial manufacture. Moreover, I gained a comprehensive understanding of and gained troubleshooting experience in the development, transfer and validation of analytical methods. I formulated and developed a strategic vision plan for the QC laboratory to modernise equipment, procedures and methods to align with current national and international regulatory expectations in pharmaceutical analysis.
  • Medpharm Ltd
    Director Of Quality
    Medpharm Ltd 2004 - 2011
    Guildford, United Kingdom
  • Micap Plc
    Senior Pharmaceutial Scientist
    Micap Plc 2002 - 2004
    Warrington, United Kingdom

Dr Michael Crothers Skills

Gmp Pharmaceutical Industry Glp Validation Formulation Quality Assurance Quality Control Change Control Pharmaceutics Hplc Sop Quality System Drug Delivery Technology Transfer Regulatory Requirements Analytical Chemistry Fda Capa Good Laboratory Practice Quality Management Quality Improvement

Dr Michael Crothers Education Details

Frequently Asked Questions about Dr Michael Crothers

What company does Dr Michael Crothers work for?

Dr Michael Crothers works for Phebra Pty Ltd

What is Dr Michael Crothers's role at the current company?

Dr Michael Crothers's current role is Chief Quality and Scientific Officer at Phebra Pty Ltd.

What is Dr Michael Crothers's email address?

Dr Michael Crothers's email address is mi****@****ail.com

What is Dr Michael Crothers's direct phone number?

Dr Michael Crothers's direct phone number is +190978*****

What schools did Dr Michael Crothers attend?

Dr Michael Crothers attended The University Of Manchester, The University Of Manchester, Queen's University Belfast.

What skills is Dr Michael Crothers known for?

Dr Michael Crothers has skills like Gmp, Pharmaceutical Industry, Glp, Validation, Formulation, Quality Assurance, Quality Control, Change Control, Pharmaceutics, Hplc, Sop, Quality System.

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