Anna-Myra Koopmans
Director QA/QP at BioConnection B.V.- Claim this Profile
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Bio
Henk Nugteren
Anna-Myra Koopmans is a dedicated, result oriented and knowledgable professional/pharmacist . During her 20+ years career in the pharmaceutical industry she gained a wealth of experience in various roles in Quality, Manufacturing and Project Management. She has a profound knowledge of all relevant technical, production, quality and compliance systems in the industry. She has managed teams of professionals and has been responsible for leading numerous inspections.of key health authorities like FDA. Anna-Myra has a good sense for human relationships and is a committed teamplayer.
Mireille Sanders
I enjoyed working with Anna-Myra over the last 4 years. She is an outstanding people manager and team builder with a very thorough background in (sterile) operations and quality. Her in depth understanding of the regulatory environment with respect to guidelines and auditing, has strengthened our operations organization tremendously. She is very pragmatic, result oriented and takes decisions in a balanced and quick way. After almost 20 years in a commercial environment, she adapted to the clinical supplies/development environment very quickly.
Henk Nugteren
Anna-Myra Koopmans is a dedicated, result oriented and knowledgable professional/pharmacist . During her 20+ years career in the pharmaceutical industry she gained a wealth of experience in various roles in Quality, Manufacturing and Project Management. She has a profound knowledge of all relevant technical, production, quality and compliance systems in the industry. She has managed teams of professionals and has been responsible for leading numerous inspections.of key health authorities like FDA. Anna-Myra has a good sense for human relationships and is a committed teamplayer.
Mireille Sanders
I enjoyed working with Anna-Myra over the last 4 years. She is an outstanding people manager and team builder with a very thorough background in (sterile) operations and quality. Her in depth understanding of the regulatory environment with respect to guidelines and auditing, has strengthened our operations organization tremendously. She is very pragmatic, result oriented and takes decisions in a balanced and quick way. After almost 20 years in a commercial environment, she adapted to the clinical supplies/development environment very quickly.
Henk Nugteren
Anna-Myra Koopmans is a dedicated, result oriented and knowledgable professional/pharmacist . During her 20+ years career in the pharmaceutical industry she gained a wealth of experience in various roles in Quality, Manufacturing and Project Management. She has a profound knowledge of all relevant technical, production, quality and compliance systems in the industry. She has managed teams of professionals and has been responsible for leading numerous inspections.of key health authorities like FDA. Anna-Myra has a good sense for human relationships and is a committed teamplayer.
Mireille Sanders
I enjoyed working with Anna-Myra over the last 4 years. She is an outstanding people manager and team builder with a very thorough background in (sterile) operations and quality. Her in depth understanding of the regulatory environment with respect to guidelines and auditing, has strengthened our operations organization tremendously. She is very pragmatic, result oriented and takes decisions in a balanced and quick way. After almost 20 years in a commercial environment, she adapted to the clinical supplies/development environment very quickly.
Henk Nugteren
Anna-Myra Koopmans is a dedicated, result oriented and knowledgable professional/pharmacist . During her 20+ years career in the pharmaceutical industry she gained a wealth of experience in various roles in Quality, Manufacturing and Project Management. She has a profound knowledge of all relevant technical, production, quality and compliance systems in the industry. She has managed teams of professionals and has been responsible for leading numerous inspections.of key health authorities like FDA. Anna-Myra has a good sense for human relationships and is a committed teamplayer.
Mireille Sanders
I enjoyed working with Anna-Myra over the last 4 years. She is an outstanding people manager and team builder with a very thorough background in (sterile) operations and quality. Her in depth understanding of the regulatory environment with respect to guidelines and auditing, has strengthened our operations organization tremendously. She is very pragmatic, result oriented and takes decisions in a balanced and quick way. After almost 20 years in a commercial environment, she adapted to the clinical supplies/development environment very quickly.
Experience
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BioConnection
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Netherlands
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director QA/QP
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Jan 2016 - Present
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MSD Netherlands
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Netherlands
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Pharmaceutical Manufacturing
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700 & Above Employee
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Qualified Person; Investigational Medicinal Products at Research and Commercialization Quality Oss
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Jan 2015 - Dec 2015
As Qualified Person I am responsible for / involved in:* Release of Drug Product and material for manufacturing,* Deviation and Change Management,* Giving Guidance on specification setting and stability,* Audit and inspections (governmental and customer),* Deputy Site Quality Head Investigational Medicinal Products
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Process Lead Commercialization Operations Oss
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Jul 2011 - Dec 2014
GSTC Operations Oss is responsible for the production and packaging (Early Phase) of clinical and development materials. The Process Lead has a team of Project managers and process Specialist who coordinate the production and packaging of pharmaceutical clinical products and improvement projects. Also the management of several overall GMP systems for the department is in the process group. As Process Lead I was Responsible for: • Overall mid and long term planning of the pilot plant• Approval of Deviations and CAPA's and Quality Manual procedures• Owner of several Quality Sub Systems (Documentation, Clinical Supply, Media fills)• Mediafill Strategy and annual reports• SOP management• Training strategy and system• Quality Metrics Show less
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Group leader Operation Project Management
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May 2011 - Jul 2011
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ad interm Head Quality Systems
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Feb 2010 - May 2011
From Feb 2010 till May 2011 I became responsible (along with the section leader function) for the Quality systems department. This department has 21 persons and extended my responsibility with:- Quality Metrics- Coordination of the Site Quality Counsel- GMP training- Change Control Coordination- Permits and licenses - Site Master File- Secretariat
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Section leader compliance and control; QA/Quality Systems
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2003 - Feb 2010
The main responsibilities of the Compliance and Control section were: - The Quality review and approval of the GMP documentation (procedures, qualification and validation documents); - The GMP role in projects- The planning and execution of the internal audit program- The planning and execution of the external audit program of suppliers and contractors - The preparation, guidance and follow up of inspections by authorities and clients. - General GMP adviceThe role in the new building project CP included all the Quality Assurance aspects. In this state of the art facility vials with solution and freeze dried product and NuvaRing are produced. My responsibilities included:- Member of the Project Leadership Team- quality/gmp aspects of the factory lay out- discussing the concepts with Dutch inspectorate and Sterile Subject Matter Experts of the FDA- Supplier audits- Design reviews- Qualification approach - Validation master plan- Quality approval of qualification and validation documents- Approval by the Dutch inspectorate. Show less
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Organon
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Production Pharmacist Special Products Department
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May 2002 - Dec 2002
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Production Pharmacist Parenteral Production Department
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1997 - May 2002
- Pharmaceutical responsibility for the production - Determination and follow up of deviations during production. The root cause investigations and discussions with Qualified Persons. - The creation of (Master) Batch Manufacturing Records and procedures. - Approval of validations and projects and registration modules - Initiation of the change controle system and and approval of change - Representative in the MES project (electronic batch record).
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Quality Officer at QA/Quality Systems
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Jan 1992 - 1997
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Validatie medewerker Tablet Production Department
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Jun 1991 - Dec 1991
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Education
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1984 - 1991
Universiteit Utrecht
Pharmacist, Farmacie
Community
