External Audits & Self-inspections

Pharmaceutical professional with over 40 years of expertise in the pharmaceutical industry, focusing on Quality Assurance (QA), Good Manufacturing Practice (GMP), and regulatory affairs. René Maassen has been the director of Pharmaceutical Consultancy Services (PCS) since 2003 - up to 2014, providing consultancy on all aspects of QA, GMP, and regulatory affairs in the pharmaceutical, biotechnology, and related healthcare industries.

Expertise and Services:

• Consultancy in QA, GMP, and Regulatory Affairs.
• Qualified Person (QP) under EU Directive 2001/83.
• Training and auditing for pharmaceutical companies.
• Support in setting up and implementing quality systems.

Previous Positions:

• Inspector for pharmaceutical companies at the Health Care Inspectorate (1996-2003):

  • Responsible for inspecting industrial manufacturing operations in the Netherlands and, upon request by the EMA, also outside Europe.
  • Head of the group of GMP and GCP inspectors.
  • Deputy Chief Inspector for Pharmacy and Medical Technology.

• Manager QA/QC and Qualified Person at Solvay Pharmaceuticals (1984-1996):

  • Responsible for quality assurance and quality control within the organization.

• Production Pharmacist at Solvay Pharmaceuticals (1981-1984):

  • Responsible for production processes and compliance with GMP guidelines.

• Community Pharmacist (1980):

  • Worked in two different public pharmacies.

Education and Qualifications:

• Pharmacist degree from the University of Amsterdam (1973-1980).
• Qualified as a Qualified Person under EC Directive 2001/83 since 1984.
• Member of the Society of Dutch Industrial Pharmacists since 1981.
• Member of the Parenteral Drug Association (PDA) since 1994.

Languages:

• Dutch: Native language.
• English: Fluent in speaking; proficient in writing.
• German: Fluent in speaking; proficient in writing.
• French: Working knowledge.

Pharmaceutical professional with over 40 years of expertise in the pharmaceutical industry, focusing on Quality Assurance (QA), Good Manufacturing Practice (GMP), and regulatory affairs. René Maassen has been the director of Pharmaceutical Consultancy Services (PCS) since 2003 - up to 2014, providing consultancy on all aspects of QA, GMP, and regulatory affairs in the pharmaceutical, biotechnology, and related healthcare industries.

Expertise and Services:

• Consultancy in QA, GMP, and Regulatory Affairs.
• Qualified Person (QP) under EU Directive 2001/83.
• Training and auditing for pharmaceutical companies.
• Support in setting up and implementing quality systems.

Previous Positions:

• Inspector for pharmaceutical companies at the Health Care Inspectorate (1996-2003):

  • Responsible for inspecting industrial manufacturing operations in the Netherlands and, upon request by the EMA, also outside Europe.
  • Head of the group of GMP and GCP inspectors.
  • Deputy Chief Inspector for Pharmacy and Medical Technology.

• Manager QA/QC and Qualified Person at Solvay Pharmaceuticals (1984-1996):

  • Responsible for quality assurance and quality control within the organization.

• Production Pharmacist at Solvay Pharmaceuticals (1981-1984):

  • Responsible for production processes and compliance with GMP guidelines.

• Community Pharmacist (1980):

  • Worked in two different public pharmacies.

Education and Qualifications:

• Pharmacist degree from the University of Amsterdam (1973-1980).
• Qualified as a Qualified Person under EC Directive 2001/83 since 1984.
• Member of the Society of Dutch Industrial Pharmacists since 1981.
• Member of the Parenteral Drug Association (PDA) since 1994.

Languages:

• Dutch: Native language.
• English: Fluent in speaking; proficient in writing.
• German: Fluent in speaking; proficient in writing.
• French: Working knowledge.