ConsultantServices include:- auditing, preparing companies for (authorised body) inspection- design and implementation of quality systems both in development and manufacturing- project management, including lean six sigma projects- management support, training and coaching

1 week - assistance in authorized body inspection.

- Managing QA systems to define, implement and assure compliance to appropriate (regulatory) guidelines regarding pharmaceutical practices- Involved as Qualified Person in development and manufacture of (biotechnological) drugs- Planning, execution and monitoring of activities regarding medical gases- Planning, execution and monitoring of quality related activities regarding pharmaceutical patient care and clinical research

- Responsible for final disposition to customers of cell banks and bulk pharmaceutical products and managing relating activities (Qualified Person)- Advise to project organization and customers on all relevant cGMP matters and assuring appropriate cGMP level of project activities- Managing QA systems to define, implement and assure compliance to cGMP policies for these systems, including proposing and implementation of improvements- Providing assistance and informing departments about changes in regulatory guidelines and supporting customers in regulatory guidelines related to the submission and maintenance of their product applications and approved licenses- Hosting FDA and EMA audits

- Management of pharmacy section of Clinical Pharmacology Unit- Responsible for all aspects of production and accountability of investigational medicinal product (IMP) and other drug products (NIMP) used during clinical studies- Implementation of new techniques within pharmacy section- Release of drug products for clinical use (Qualified Person)

- Management of Medical Department, responsible for Research & Development, Regulatory Affairs, Quality Assurance, Quality Control and Training & Education divisions- Responsible for quality system and regulatory submissions- Release of drug products (Qualified Person) and physiotherapy products (Food law)