Ricardo Mikan has over 15 years of experience in quality control, quality management, and R&D for multinational pharmaceutical companies. He has a background in chemical engineering, industrial pharmacy, and industrial administration. In his current role as Analytical Development Manager for Stiefel Laboratories, a GSK company, he manages external service providers and performs audits. He also supports regulatory affairs and manages important projects. Previously he held supervisory roles at Stiefel Laboratories and Pfizer Laboratories where he led teams and was responsible for quality control, process validation, stability studies, and technical support.

1. RICARDO MIKAN
Address: Rua Pedro de Godói, 269 – apt. 54C - Vila Prudente - São Paulo.
Phone: (11) 94281-7641; e-mail: ricardo.mikan@gmail.com
Background Summary
 Over 15 years’ experience in multinational pharmaceutical industries.
 Graduated in Chemical Engineering and Industrial Pharmacy with post graduation in Industrial
Administration.
 R&D Site Audit & Risk Management Champion.
 Vast experience in Quality Control, Managing Laboratories, Quality Systems principles and practical
application, Quality and Risk Management principles and tools
 Excellent intercultural skills, capability of working with multicultural and distant teams, supporting third
parties in Brazil, US, India, Mexico and UK in the development of new products, methodology and
transfer of technology to be adopted at local sites.
 Experience in negotiation abilities and able to negotiate with external companies with a focus on
customers and autonomy to take important decisions, including batch disposition.
 Experience in working independently with good judgment, flexible work demands, excellent verbal and
written communication skills in Portuguese, English and Spanish.
 Large experience to manage technical meetings to investigate results out of specification, standard
deviation, out of trend and root cause analysis in third parties by teleconference.
 Experience in conducting and manage activities in third parties to ensure the delivery of the activities
on time and according to GSK standards.
Professional Background
Stiefel Laboratories, a GSK company
2009 to present
Analytical Development Manager
Main responsibilities:
 Managing global external service providers, agreeing lead time, deliverables, quality agreements,
budget, service level (SLA), driving them to reach targets.
 Perform internal audits (L1 and L2) on R&D department including risk management, identifying
gaps in local and global guidelines. Escalating risks (Global Quality Alert) and managing CAPA
implementation.
 Service provider qualification performing audits (L3) on third party laboratories.
 Support Regulatory Affairs providing product information file and technical assistance in order to
register new products.
 Team member of important projects, site remediation and cost reduction management
 Manage product flow importation to guarantee quality and on-time delivery so as to perform
clinical studies on CROs.
 Assure that all R&D employees are duly trained to perform their tasks correctly and efficiently.

2. Stiefel Laboratories
2002 to 2009
Quality Control Supervisor
Main responsibilities:
 Leading up to 30 employees, improving the performance of the laboratory to attend greater
production demand of 8% per year and reducing internal costs by 6% per year and adjusting activities
between departments.
 Develop people for future promotion including team motivation eyeing continuous improvement,
company focus and team work.
 Revise and control annual budget and investment plan.
 Supervise the annual stability study following local legislation.
 Provide technical support to production for the implementation of new materials looking for positive
impacts on the production and quality of the product.
Pfizer Laboratories
1998 to 2002
Technical Support Analyst and Trainee
Main responsibilities:
 Provide technical support to the production area to help solve problems in relation to product quality
and lack of efficiency.
 Help in the development of new products including raw materials for creams, ointments, tablets and
sterile products.
 Process validation for the sterile products and tablet lines to reduce production time and rework.
 Perform stability studies on new products.